Pneumatically powered surgical cutting and fastening instrument with audible and visual feedback features

ABSTRACT

A surgical instrument for use in connection with a pneumatically powered tool having a firing mechanism operably supported therein that is movable between an unactuated position and an actuated position. A pneumatically powered drive system operably communicates with the pneumatically powered tool and is configured to selectively apply at least a firing force to the firing mechanism of the pneumatically powered tool of sufficient magnitude to cause the firing mechanism to move from the unactuated position to the actuated position in response to a flow of gas from a source of gas that is fluidically coupled to the pneumatically powered drive system. At least one feedback device communicates with the pneumatically powered drive system for providing feedback concerning at least one of: 
     (a) the magnitude of the firing force as the pneumatically powered drive system moves the firing mechanism from the unactuated to actuated position; and 
     (b) a relative position of the firing mechanism as the firing mechanism is moved between the unactuated and actuated positions.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is related to the following concurrently-filed U.S.patent applications, which are incorporated herein by reference:

(1) PNEUMATICALLY POWERED SURGICAL CUTTING AND FASTENING INSTRUMENT WITHACTUATOR AT DISTAL END; Inventors: Frederick E. Shelton, IV, Jerome R.Morgan, Eugene L. Timperman, and Leslie M. Fugikawa, application Ser.No. 11/497,832;

(2) PNEUMATICALLY POWERED SURGICAL CUTTING AND FASTENING INSTRUMENT WITHA VARIABLE CONTROL OF THE ACTUATING RATE OF FIRING WITH MECHANICAL POWERASSIST; Inventors: Frederick E. Shelton, IV, Jerome R. Morgan, Eugene L.Timperman, and Leslie M. Fugikawa, application Ser. No. 11/497,898;

(3) PNEUMATICALLY POWERED SURGICAL CUTTING AND FASTENING INSTRUMENT WITHMECHANICAL LINKAGE COUPLING END EFFECTOR AND TRIGGER MOTION; Inventors:Frederick E. Shelton, IV, Jerome R. Morgan, Eugene L. Timperman, andLeslie M. Fugikawa , application Ser. No. 11/498,282;

(4) PNEUMATICALLY POWERED SURGICAL CUTTING AND FASTENING INSTRUMENT WITHREPLACEABLE POWER SOURCES; Inventors: Frederick E. Shelton, IV, JeromeR. Morgan, Eugene L. Timperman, and Leslie M. Fugikawa, application Ser.No. 11/497,831;

(5) PNEUMATICALLY POWERED SURGICAL CUTTING AND FASTENING INSTRUMENT WITHIMPROVED VOLUME STORAGE; Inventors: Frederick E. Shelton, IV and JeromeR. Morgan, application Ser. No. 11/497,770;

(6) PNEUMATICALLY POWERED SURGICAL CUTTING AND FASTENING INSTRUMENT WITHMANUALLY OPERATED RETRACTION APPARATUS; Inventors: Frederick E. Shelton,IV, Jerome R. Morgan, Eugene L. Timperman, and Leslie M. Fugikawa,application Ser No. 11/497,936; and

(7) SURGICAL CUTTING AND FASTENING INSTRUMENT WITH DISTALLY MOUNTEDPNUEMATICALLY POWERED ROTARY DRIVE MEMBER; Inventors: Frederick E.Shelton, IV, Jerome R. Morgan, Eugene L. Timperman, and Leslie M.Fugikawa, application Ser No. 11/497,760.

BACKGROUND

The present invention generally concerns surgical instruments and, moreparticularly, pneumatically powered surgical cutting and fasteninginstruments. The present invention may have application in conventionalendoscopic and open surgical instrumentation as well as application inrobotic-assisted surgery.

Surgical cutting and fastening instruments (staplers) have been used inthe prior art to simultaneously make a longitudinal incision in tissueand apply lines of staples on opposing sides of the incision. Suchinstruments commonly include a pair of cooperating jaw members that, ifthe instrument is intended for endoscopic or laparoscopic applications,are capable of passing through a cannula passageway. One of the jawmembers receives a staple cartridge having at least two laterally spacedrows of staples. The other jaw member defines an anvil havingstaple-forming pockets aligned with the rows of staples in thecartridge. The instrument includes a plurality of reciprocating wedgeswhich, when driven distally, pass through openings in the staplecartridge and engage drivers supporting the staples to effect the firingof the staples toward the anvil.

Over the years, a variety of different methods for actuating the cuttingand staple deployment components have been developed. For example, U.S.Pat. No. 6,978,921 to Shelton, IV et al. discloses a surgical staplinginstrument that employs tissue severing and staple deployment componentsthat are driven through manual actuation of various trigger mechanismson the handle. Other surgical stapling apparatuses have been developedthat employ battery powered motors. Such a device is disclosed in U.S.Pat. No. 5,954,259 to Viola et al.

Still other surgical staplers are actuated by a source of pressurizedgas. For example, U.S. Pat. No. 6,619,529 to Green et al. discloses asurgical stapler that employs a source of pressurized gas in the handlethat is used to power a cylinder that is also located within the handle.The cylinder houses a piston assembly that is actuated by admission ofthe pressurized gas into the cylinder. The piston is configured to coactwith components located in the elongated tube portion and handle memberto cause the deployment of the staples and the surgical knife in thedistally mounted end effector. Such design, however, employs a complexcollection of components for transmitting the motion of thehandle-mounted piston to the components located in the end effectorportion of the device. In addition, when using such a device, there is arisk that the power source becomes depleted during the surgicalprocedure because there is no way of monitoring the amount of gasremaining in the gas cartridge. If this occurs during the firing orretraction cycles, such devices lack means for easily exchanging thespent container with a new container or auxiliary power source.

Another pneumatically powered surgical stapling device is disclosed inU.S. Patent Publication No. U.S. 2006/0151567 to Roy. This deviceemploys a pneumatically powered motor or piston system supported in thehandle of the device for creating a motion that is employed to actuatethe end effector. This device may be powered by removable cartridges orfrom an external power source, such as the hospital's existing pneumaticair or gas supply.

Such pneumatically powered devices that employ cartridges or containersin the handle portion of the device are also hampered by the size of thegas cylinder required to store the pressurized gas at sufficient volumesto facilitate actuation of the device a desired number of times at aminimum usable pressure. In the past, devices designed for large numbersof applications/procedures would either require a large cylinder to beused or, if smaller cylinders were used, such cylinders would haveundesirably high pressures. In addition, devices that employ removablecartridges that can be used an unlimited number of times must bereprocessed and resterilized. Such arrangements can dramatically changeperformance capabilities and may therefore be less desirable.

Other problems exist with prior pneumatically actuated endocutters. Forexample, once the surgeon activates the instrument through a singleswitch or activation trigger, the instrument progresses through or atleast attempts to complete the firing cycle. Thereafter, the firingcomponents may be retracted by the drive system. While the surgeonemploying the device disclosed in U.S. Patent Publication U.S.2006/0151567 can interrupt the firing cycle and/or adjust the flow ofgas to the device through a trigger assembly, there is no means tomonitor the device's progress. In addition, such prior devices lack ameans for manually retracting the knife and firing bar mechanism, shouldoperating pressure be lost or interrupted during the procedure. Further,that device lacks a means for enabling the clinician to manually applyadditional force to the drive system to assist with the advancement ofthe firing mechanism or to slow its advancement.

Consequently there is a need for a pneumatically powered surgicalstapling device that does not require the use of an extensive collectionof components to transfer the pneumatically generated stapling andfiring motions to the end effector components.

There is another need for a pneumatically powered surgical staplingdevice that provides a means for the surgeon to control and monitor theprogress of the device as it moves through the firing and retractioncycles.

There is another need for a pneumatically powered surgical staplingdevice that provides tactile and other feedback to the surgeonconcerning the forces encountered during firing and also notification ofwhen the device has reached its actuated position and is ready to beretracted.

There is a need for a pneumatically powered surgical stapling devicethat is economical and has the ability to easily interchange powersources, while limiting the number of times that such sources may beinterchanged.

There is another need for methods and apparatuses for more efficientlystoring gas in cylinders used to power surgical stapling devices suchthat more uses can be powered from a single cylinder.

There is still another need for a pneumatically powered stapling devicethat has means for manually retracting the knife and firing bar assemblyshould pneumatic power be lost or interrupted.

There is yet other need for devices with one or more of the abovementioned features and that also has an end effector that can beselectively articulated relative to the handle assembly and/or portionof the elongate shaft assembly to which it is attached.

There is still another need for devices with one or more of theabove-identified features that is also capable of accommodatingremovably attachable end effectors to facilitate use of the device inconnection with disposable end effector arrangements.

SUMMARY

In one general aspect, the present invention is directed to a surgicalinstrument for use in connection with a pneumatically powered toolhaving a firing mechanism operably supported therein that is movablebetween an unactuated position and an actuated position. In variousembodiments, the surgical instrument comprises a pneumatically powereddrive system that operably communicates with the pneumatically poweredtool and is configured to selectively apply at least a firing force tothe firing mechanism of the pneumatically powered tool of sufficientmagnitude to cause the firing mechanism to move from the unactuatedposition to the actuated position in response to a flow of gas from asource of gas fluidically coupled to the pneumatically powered drivesystem. At least one feedback device communicates with the pneumaticallypowered drive system for providing feedback concerning at least one of:

(a) the magnitude of the firing force as the pneumatically powered drivesystem moves the firing mechanism from the unactuated to actuatedposition; and

(b) a relative position of the firing mechanism as the firing mechanismis moved between the unactuated and actuated positions.

In another general aspect, the present invention is directed to asurgical instrument that comprises a handle assembly and a closure drivethat is supported by the handle assembly. The closure drive may beconfigured to generate a closing motion and an opening motion. Anelongate shaft assembly may be coupled to the handle assembly such thatit communicates with the closure drive to transfer the opening andclosing motions. A pneumatically powered drive system is supported by atleast one of the handle assembly and the elongate shaft assembly and isconfigured to selectively generate at least one of a firing force and aretraction force. The instrument may further include an end effectorthat is coupled to the elongate shaft assembly. In various embodiments,the end effector may comprise an elongate channel that is sized toreceive a staple cartridge therein. The end effector may furthercomprise an anvil that is pivotally coupled to the elongate channel andis pivotally responsive to the open and closing motions from theelongate shaft assembly. In addition, the end effector may comprise afiring mechanism that is operably supported within one of the elongatechannel and the staple cartridge and is movable from an unactuatedposition to an actuated position in response to an application of thefiring force from the drive system. The firing mechanism may further bemovable from the actuated position to the unactuated position inresponse to another application of the retraction force from the drivesystem. The surgical instrument may further comprise at least onefeedback device that communicates with the drive system for providingfeedback concerning at least one of:

(a) a magnitude of the firing force as the drive system moves the firingmechanism from the unactuated to actuated position; and

(b) a relative position of the firing mechanism as the firing mechanismis moved between the unactuated and actuated positions.

DRAWINGS

Various embodiments of the present invention are described herein by wayof example in conjunction with the following Figures, wherein likenumerals may be used to describe like parts and wherein:

FIG. 1 is a perspective view of an embodiment of a surgical cutting andfastening instrument of the present invention;

FIG. 2 is an exploded assembly view of an end effector arrangement thatmay be employed in connection with various embodiments of the presentinvention;

FIG. 3 is a top view of the end effector of FIGS. 1 and 2 with the anvilportion removed therefrom and the closure tube assembly illustrated inphantom lines;

FIG. 4 is a cross-sectional side elevational view of the end effectorarrangement of FIG. 3 with the anvil portion attached thereto and shownin an open position;

FIG. 5 is a cross-sectional top view of a portion of an articulationcontrol that may be employed with various embodiments of the presentinvention;

FIG. 6 is a top cross-sectional view illustrating the articulation ofthe end effector depicted in FIG. 1;

FIG. 7 is an exploded assembly view illustrating an embodiment of aclosure tube assembly and shuttle arrangement supported within thehandle assembly with other components housed within the housing assemblybeing omitted for clarity;

FIG. 8 is a cross-sectional view of a housing assembly arrangement ofvarious embodiments of the present invention;

FIG. 8A is a partial cross-sectional view of a portion of a closuretrigger locking system that may be employed in connection with variousembodiments of the present invention;

FIG. 8B is a cross-sectional view of another handle assembly embodimentof the present invention wherein the source of pressurized gas isexternal to the handle assembly;

FIG. 8C is a cross-sectional view of another handle assembly embodimentof the present invention;

FIG. 9 is another cross-sectional view of the handle assembly of FIG. 8;

FIG. 10 is a side view of a knife bar arrangement and a firing drivemember that comprises a two stage cylinder assembly of variousembodiments of the present invention with the cylinder assembly shown incross-section;

FIG. 11 is another side view of the knife bar and two stage cylinderarrangements depicted in FIG. 10 with the knife bar in the extendedposition;

FIG. 12 is a side view of another knife bar and firing drive memberarrangement of the present invention with the knife bar being retractedinto a cylinder assembly shown in cross-section;

FIG. 13 is another side view of the knife bar and cylinder arrangementsdepicted in FIG. 12 with the knife bar in the extended position;

FIG. 14 is a top view of an end effector and spine assembly arrangementhousing the cylinder and knife bar arrangements depicted in FIGS. 12 and13;

FIG. 15 is a cross-sectional side elevational view of the end effectorand spine assembly arrangement depicted in FIG. 14 with the anvilportion attached thereto and in the open position;

FIG. 16 is a cross-sectional view of a handle assembly that may be usedin connection with the embodiment depicted in FIGS. 12-15;

FIG. 16A is a cross-sectional view of another handle assembly that maybe used in connection with the embodiment depicted in FIGS. 12-15wherein the source of pressurized gas is external to the handleassembly;

FIG. 16B is a cross-sectional view of another handle assembly embodimentof the present invention;

FIG. 17 is a top view of another knife bar and spine assemblyarrangement that supports another firing drive member in the form of abellows assembly of another embodiment of the present invention;

FIG. 18 is a cross-sectional side elevational view of the end effectorand spine assembly arrangements of the embodiment depicted in FIG. 17;

FIG. 19 is a partial cross-sectional assembly view of a bellows assemblyof the embodiments depicted in FIGS. 17 and 18;

FIG. 20 is an enlarged view of a portion of the bellows assembly of FIG.19;

FIG. 21 is a cross-sectional view of a handle assembly embodiment thatmay be used in connection with the embodiments depicted in FIGS. 17-20;

FIG. 21A is a cross-sectional view of another handle assembly embodimentthat may be used in connection with the embodiments of FIGS. 17-20wherein the source of pressurized gas is external to the handleassembly;

FIG. 21B is a cross-sectional view of another handle assembly embodimentof the present invention;

FIG. 22 is a perspective view of another surgical cutting and fasteninginstrument according to other embodiments of the present invention;

FIG. 23 is a cross-sectional side elevational view of the end effectorand spine assembly of the embodiment depicted in FIG. 22;

FIG. 24 is a cross-sectional view of the quick disconnect jointarrangement of the embodiment of FIGS. 22 and 23 prior to coupling thedistal shaft assembly to the proximal shaft assembly;

FIG. 25 is a cross-sectional view of the proximal shaft assembly takenalong line 25-25 in FIG. 24;

FIG. 26 is a partial perspective view of the distal shaft assemblyattached to the proximal shaft assembly with a portion of the distalshaft assembly omitted for clarity;

FIG. 27 is a cross-sectional side elevational view of the joint assemblyof the embodiments of FIGS. 24-26 with the distal shaft assembly coupledto the proximal shaft assembly;

FIG. 28 is a perspective view of a portion of the distal shaft assemblyprior to attachment to a portion of the proximal shaft assembly;

FIG. 29 is a partial cross-sectional view of another quick disconnectjoint arrangement that may be employed with the embodiment depicted inFIGS. 12-16A;

FIG. 30 is a cross-sectional view of the proximal shaft assembly takenalong line 30-30 in FIG. 29;

FIG. 31 is a perspective view of a portion of a proximal shaft assemblythat may be used in connection with the embodiments depicted in FIGS.22-30;

FIG. 32 is a perspective view of another surgical cutting and fasteninginstrument of the present invention that employs a pneumaticallyactuated articulation joint of various embodiments of the presentinvention;

FIG. 33 is a partial perspective view of a portion of the articulationjoint attaching a distal spine segment to a proximal spine segment ofthe embodiment depicted in FIG. 32;

FIG. 34 is another perspective view of the articulation jointarrangement of FIG. 33 with the cover removed therefrom and illustratingthe distal spine segment articulated relative to the proximal spinesegment;

FIG. 35 is an exploded assembly view of the articulation jointarrangement of FIGS. 33 and 34;

FIG. 36 is a cross-sectional side view of the joint assembly of FIGS.33-35;

FIG. 37 is a perspective view of a switch assembly embodiment of thepresent invention;

FIG. 38 is a side elevational view of the switch assembly of FIG. 37;

FIG. 39 is a cross-sectional view of the switch assembly of FIGS. 37 and38 taken along line 39-39 in FIG. 37;

FIG. 40 is a cross-sectional view of the switch assembly in the offposition taken along line 40-40 in FIG. 38;

FIG. 41 is another cross-sectional view of the switch assembly of FIGS.37-40 in an actuated position;

FIG. 42 is a cross-sectional view of the switch assembly of FIG. 41taken along line 42-42 in FIG. 41;

FIG. 43 is a bottom view of the switch assembly of FIGS. 37-42;

FIG. 44 is a cross-sectional view of a handle assembly that has theswitch assembly of FIGS. 37-43 therein and houses a source ofpressurized gas;

FIG. 45 is a cross-sectional view of a handle assembly that has theswitch assembly of FIGS. 37-43 therein and wherein the source ofpressurized gas is external to the handle assembly;

FIG. 46 is a perspective view of another surgical stapling and cuttinginstrument of the present invention that employs the articulation jointembodiments depicted in FIGS. 33-36 and the quick disconnect jointembodiments depicted in FIGS. 23-31;

FIG. 47 is a cross-sectional view of the quick disconnect jointarrangement of the embodiment of FIG. 46 prior to coupling the distalshaft assembly to the proximal shaft assembly;

FIG. 48 is a cross-sectional view of the joint assembly of theembodiments of FIG. 47 taken along line 48-48 in FIG. 47;

FIG. 49 is a perspective view of another surgical cutting and fasteninginstrument embodiment of the present invention;

FIG. 50 is an exploded assembly view of an end effector arrangement thatmay be employed in connection with the embodiment depicted in FIG. 49;

FIG. 51 is an exploded assembly view of an end effector arrangement,spine assembly and closure tube assembly that may be employed inconnection with the embodiment depicted in FIG. 49;

FIG. 52 is a cross-sectional side elevational view of the end effector,spine assembly and closure tube assembly of FIG. 51 with the anvilportion omitted for clarity;

FIG. 52A is a cross-sectional side elevational view of an end effector,spine assembly and closure tube assembly of another non-limitingembodiment of the present invention wherein the pneumatically poweredmotor is supported distally from the handle assembly;

FIG. 52B is a cross-sectional side elevational view of an end effector,spine assembly and closure tube assembly of another non-limitingembodiment of the present invention wherein the pneumatically poweredmotor is supported distally from the handle assembly;

FIG. 53 is a cross-sectional view of a handle assembly that may beemployed in connection with the embodiment of FIG. 49;

FIG. 53A is a cross-sectional view of another handle assembly that maybe employed with the embodiment of FIG. 49 wherein the source ofpressurized gas is external to the handle assembly;

FIG. 54 is another cross-sectional view of the handle assembly of FIG.53;

FIG. 55 is a side view of a relative position firing trigger arrangementof various embodiments of the present invention;

FIG. 56 is a schematic of a control system embodiment of the presentinvention that may be employed in connection with various embodiments ofthe present invention;

FIG. 57 is a cross-sectional view of a detachable grip portion detachedfrom a primary attachment portion of various handle assembly embodimentsof the present invention;

FIG. 58 is a partial cross-sectional view showing the detachable gripportion coupled to the primary attachment portion of a handle assemblyof various embodiments of the present invention;

FIG. 59 is a partial cross-sectional view of the detachable grip portionand primary attachment portion of FIG. 58 with the headers andcylinder-related components omitted for clarity;

FIG. 60 is a cross-sectional view of the detachable grip portion andprimary attachment portion of FIGS. 58 and 59 taken along line 60-60 inFIG. 59;

FIG. 61 is a cross-sectional view of the detachable grip portion andprimary attachment portion of FIGS. 58, 59, and 60 taken along line61-61 in FIG. 59;

FIG. 62 is a cross-sectional view of the detachable grip portion andprimary attachment portion of FIGS. 58-61 taken along line 62-62 in FIG.59;

FIG. 63 is another partial cross-sectional view of the detachable gripportion and primary attachment portion of FIGS. 58-62 taken along line63-63 in FIG. 59;

FIG. 64 is a diagrammatic view of a lockout system embodiment of thepresent invention in an initial position;

FIG. 65 is another diagrammatic view of the lockout system of FIG. 64illustrating the action thereof when the grip portion is initiallyattached to the primary attachment portion of the handle assembly;

FIG. 66 is another diagrammatic view of the lock out system of FIGS. 64and 65 prior to the second detachment of the grip portion from theprimary attachment portion of the handle assembly;

FIG. 67 is another diagrammatic view of the lock out system of FIGS.64-66 that illustrates the positions of the system components when thegrip portion has been attached to the primary attachment portion;

FIG. 68 is another diagrammatic view of the lock out system of FIGS.64-67 that illustrates the position of the system components during thesecond attachment of the grip portion to the primary attachment portion;

FIG. 69 is another diagrammatic view illustrating the lock out systemafter the grip portion has been attached to the primary attachmentportion for the second and final time;

FIG. 70 is a perspective view of another surgical cutting and fasteninginstrument embodiment of the present invention;

FIG. 71 is a cross-sectional view of a handle assembly embodiment thatmay be employed in connection with the instrument depicted in FIG. 70;

FIG. 72 is an exploded assembly view of a shuttle and retraction rodassembly of various embodiments of the present invention;

FIG. 72A is an exploded assembly view of a shuttle and retraction rodassembly of other embodiments of the present invention;

FIG. 73 is an assembled view of the components depicted in FIG. 72 withthe cylinder assembly thereof in a fully extended position;

FIG. 74 is a rear elevational view of a shuttle assembly embodiment ofthe present invention;

FIG. 75 is another rear elevational view of the shuttle assembly of FIG.74 with the retraction rod and push bar extending into the push baropening and with the push bar attached to the connector member;

FIG. 76 is a rear elevational perspective view of the left side portionof the shuttle assembly;

FIG. 77 is another rear elevational perspective view of the left sideportion of the shuttle assembly;

FIG. 78 is a schematic depiction of a control system arrangement thatmay be used with the embodiments depicted in FIGS. 70-77;

FIG. 79 is a top cross-sectional view of a handle assembly arrangementof the embodiments depicted in FIGS. 70-78 with the cylinder assembly inan extended position;

FIG. 80 is another top cross-sectional view of a handle assemblyarrangement of the embodiments depicted in FIGS. 70-79 with the cylinderassembly in a retracted position;

FIG. 81 is a cross-sectional view of a handle assembly of theembodiments depicted in FIGS. 70-80;

FIG. 81A is a cross-sectional view of a handle assembly embodiment thatmay be employed with the embodiment depicted in FIGS. 70-80 wherein thesource of pressurized gas is external to the handle assembly;

FIG. 82 is another cross-sectional view of the handle assembly of FIG.81 wherein cylinder assembly is extended;

FIG. 83 is another cross-sectional view of the handle assembly of FIG.81 wherein cylinder assembly is retracted; and

FIG. 83A is a cross-sectional view of a handle assembly of theembodiment depicted in FIG. 72B wherein the cylinder assembly isretracted and the firing rod is in its proximal most position.

DETAILED DESCRIPTION

Turning to the Drawings wherein like numerals denote like componentsthroughout the several views, FIG. 1 depicts a surgical stapling andsevering instrument 10 that is capable of practicing several uniquebenefits of the present invention. The embodiment illustrated in FIG. 1includes a handle assembly 300, an elongate shaft assembly 100, and anend effector 12 that is connected to the elongate shaft assembly 100.Various embodiments of the present invention may include an end effectorthat is pivotally attached to the elongate shaft assembly 100 andpivotally driven by bending cables or bands such as those disclosed inU.S. patent application Ser. No. 11/329,020, filed Jan. 10, 2006, U.S.Patent Publication No. Us-2007-0158385 A1 entitled “SURGICAL INSTRUMENTHAVING AN ARTICULATING END EFFECTOR”, the disclosure of which is hereinincorporated by reference. However, as the present Detailed Descriptionproceeds, those of ordinary skill in the art will appreciate thatvarious embodiments of the present invention may be successfullypracticed in connection with end effector arrangements that employdifferent pivoting mechanisms and controls and, as will be explained infurther detail below, may even be successfully employed withnon-articulating end effector arrangements.

As can be seen in FIG. 1, the handle assembly 300 of the instrument 10may include a closure trigger 302 and a firing trigger 310. It will beappreciated that instruments having end effectors directed to differentsurgical tasks may have different numbers or types of triggers or othersuitable controls for operating an end effector. The end effector 12 isshown separated from the handle assembly 300 by the preferably elongateshaft assembly 100. A clinician may articulate the end effector 12relative to the shaft assembly 100 by utilizing an articulation control200.

It should be appreciated that spatial terms such as vertical,horizontal, right, left etc., are given herein with reference to thefigures assuming that the longitudinal axis of the surgical instrument10 is co-axial to the central axis of the elongate shaft assembly 100,with the triggers 302, 310 extending downwardly at an acute angle fromthe bottom of the handle assembly 300. In actual practice, however, thesurgical instrument 10 may be oriented at various angles and, as such,these spatial terms are used relative to the surgical instrument 10itself. Further, “proximal” is used to denote a perspective of aclinician who is behind the handle assembly 300 who places the endeffector 12 distal, or away from him or herself.

As used herein, the term, “pressurized gas” refers to any gas suitablefor use in pneumatically powered systems employed in a sterileenvironment. Non-limiting examples of such mediums include compressedair, carbon dioxide (CO2), Nitrogen, Oxygen, Argon, Helium, SodiumHydride, Propane, Isobutane, Butane Chlorofluorocarbons, Dimethyl ether.Methyl ethyl ether, Nitrous Oxide, Hyrdofluoroalkanes (HFA)—either, forexample, HFA 134a (1,1,1,2,-tetrafluoroethane) or HFA 227(1,1,1,2,3,3,3-heptafluoropropane).

As used herein, the term “fluidically coupled” means that the elementsare coupled together with an appropriate line or other means to permitthe passage of pressurized gas therebetween. As used herein, the term“line” as used in “supply line” or “return line” refers to anappropriate passage formed from rigid or flexible conduit, pipe, tubing,etc. for transporting pressurized gas from one component to another.

As used herein the terms “pneumatic signal” or “pneumatic drive signal”refer to the flow of gas from a source of pressurized gas to one or morecomponents that are fluidically coupled to the source of pressurized gasor the flow of gas between components that are fluidically coupledtogether.

As used herein, the phrase, “substantially transverse to thelongitudinal axis” where the “longitudinal axis” is the axis of theshaft, refers to a direction that is nearly perpendicular to thelongitudinal axis. It will be appreciated, however, that directions thatdeviate some from perpendicular to the longitudinal axis are alsosubstantially transverse to the longitudinal axis.

FIG. 2 illustrates an exploded assembly view of one type ofpneumatically operated tool assembly or end effector that may beemployed in various embodiments of the present invention. Thepneumatically operated tool assembly 12 shown in FIGS. 1-4 is configuredto act as an endocutter. As the present Detailed Description proceeds,however, it will be appreciated that various unique and novel drivearrangements of embodiments of the present invention could also beconceivably employed to drive other end effectors configured to performother surgical tasks and thus requiring the removal, modification, oraddition of components from what is shown in the Figures. Also, it willbe appreciated that the end effectors 12 shown in FIGS. 1-4 may becustomized for specific surgical applications.

One type of end effector that may be employed with various embodimentsof the present invention is depicted in FIG. 2. As can be seen in thatFigure, the end effector 12 employs an E-beam firing mechanism (“knifeassembly”) 30 that, in addition to cutting tissue and firing stapleslocated in a staple cylinder seated therein, advantageously controls thespacing of an anvil portion of the end effector 12 relative to thestaple cylinder. Various aspects of E-beam firing mechanisms aredescribed in U.S. Pat. No. 6,978,921, entitled Surgical StaplingInstrument Incorporating An E-Beam Firing Mechanism to Shelton, IV. etal., the relevant portions of which are herein incorporated byreference. As the present Detailed Description proceeds, however, thoseof ordinary skill in the art will appreciate that other knife and firingmechanism configurations may be advantageously employed withoutdeparting from the spirit and scope of the present invention.

As used herein, the term “firing mechanism” refers to the portion orportions of the pneumatically powered tool and/or end effector that movefrom an unactuated position wherein the firing mechanism may beessentially at rest to an actuated or end position wherein that portionor portions have been moved or repositioned to a final position whereinsuch movement thereof resulted in the tool completing one or moreactions in response to the application of at least one firing motionthereto. The firing mechanism may comprise, for example: (i) componentsthat are completely supported by the pneumatically powered tool andinterface with components in the surgical device; (ii) a combination ofcomponents that are located in the pneumatically powered tool and in thesurgical device; or (ii) components that are supported by the surgicaldevice and are movable into and out of the pneumatically powered tool.As used herein, the term “firing stroke” refers to the actual movementof the firing mechanism from the unactuated position to the actuatedposition. The term “retraction stroke” refers to the return movement ofthe firing mechanism from the actuated position to the unactuatedposition.

As can be seen in FIG. 2, the end effector 12 includes a distal memberthat, in various non-limiting embodiments, comprise an elongate channel20 that has a pivotally translatable anvil 40 attached thereto. Theelongate channel 20 is configured to receive and support a staplecartridge 50 that is responsive to the knife assembly 30 to drivestaples 70 into forming contact with the anvil 40. It will beappreciated that, although a readily replaceable staple cartridge isadvantageously described herein, a staple cartridge consistent withaspects of the present invention may be permanently affixed or integralto the elongate channel 20.

In various embodiments, the firing mechanism or knife assembly 30includes vertically spaced pins that control the spacing of the endeffector 12 during firing. In particular, upper pins 32 are staged toenter an anvil pocket 42 near the pivot between the anvil 40 andelongate channel 20. See FIG. 4. When fired with the anvil 40 closed,the upper pins 32 advance distally within a longitudinal anvil slot 44extending distally through anvil 40. Any minor upward deflection in theanvil 40 is overcome by a downward force imparted by the upper pins 32.

Knife assembly 30 also includes a knife bar cap 34 that upwardly engagesa channel slot 23 (FIG. 2) formed in the elongate channel 20, therebycooperating with the upper pins 32 to draw the anvil 40 and the elongatechannel 20 slightly closer together in the event of excess tissueclamped therebetween. In various embodiments, the knife assembly 30 mayadvantageously include middle pins 36 that pass through a firing driveslot (not shown) formed in a lower surface of the cartridge 50 and anupward surface of the elongate channel 20, thereby driving the staples70 therein as described below. The middle pins 36, by sliding againstthe elongate channel 20, advantageously resist any tendency for the endeffector 12 to be pinched shut at its distal end. However, the uniqueand novel aspects of various embodiments of the present invention may beattained through use of other knife assembly arrangements.

Returning to FIG. 2, a distally presented cutting edge 38 between theupper and middle pins 32, 36 on the knife assembly 30 traverses througha proximally presented, vertical slot 54 in the cartridge 50 to severclamped tissue. The affirmative positioning of the knife assembly 30with regard to the elongate channel 20 and anvil 40 assure that aneffective cut is performed. In various embodiments, the lower surface ofthe anvil 40 may be provided with a plurality of staple forming pocketstherein (not shown) that are arrayed to correspond to a plurality ofstaple apertures 58 in an upper surface 56 of the staple cartridge 50when the staple cartridge 50 is received within the elongate channel. Invarious embodiments, the staple cartridge 50 may be snap fit into theelongate channel 20. Specifically, extension features 60, 62 of thestaple cartridge 50 frictionally and releasably engage recesses 24, 26,respectively of the elongate channel 20.

As can also be seen in FIG. 2, the staple cartridge 50 comprises acartridge body 51, a wedge sled 64, staple drivers 66, staples 70, and acartridge tray 68. When assembled, the cartridge tray 68 holds the wedgesled 64, staple drivers 66, and staples 70 inside the cartridge body 51.The elongate channel 20 is coupled to the handle assembly 300 by theelongate shaft assembly 100 which includes a distal spine or framesection 110 and a proximal spine or frame section 130. The elongatechannel 20 has proximally placed attachment cavities 22 that eachreceive a corresponding channel anchoring member 114 formed on thedistal end of the distal spine section 110. The elongate channel 20 alsohas anvil cam slots 28 that pivotally receive a corresponding anvilpivot 43 on the anvil 40. A closure sleeve assembly 170 is received overthe spine assembly 102 and includes distal closure tube segment 180 anda proximal closure tube segment 190. As will be discussed below, axialmovement of the closure sleeve assembly 170 relative to the spineassembly 102 causes the anvil 40 to pivot relative to the elongatechannel 20.

As can be seen in FIG. 2, a locking spring 112 is mounted in the distalspine segment 110 as a lockout for the knife assembly 30. Distal andproximal square apertures 111, 113 are formed on top of the distal spinesegment 110 to define a clip bar 115 therebetween that receives a toparm 116 of the locking spring 112 whose lower, distally extended arm 118asserts a downward force on a distal end of a cylinder assembly 501supporting the piston bar portion 35 protruding from the knife assembly30 as will be discussed in further detail below. It will be appreciatedthat various embodiments may include other types of lockouts or nolockouts at all.

In the embodiment depicted in FIGS. 1-6, the end effector 12 may bearticulated relative to the proximal closure tube segment 190 (andhandle assembly 300) by a collection of cables or bands that are bent topull the end effector 12 about a pivot 104. Those of ordinary skill inthe art will understand that such arrangement represents just one ofmany articulation arrangements that may be employed in connection withthese types of devices. In this embodiment, the proximal end of thedistal spine segment 110 has a boss 122 thereon. The distal end of theproximal spine segment 130 is provided with a tang 134 that has anaperture 136 therethrough. The proximal spine segment 130 is positionedrelative to the distal spine segment 110 such that the aperture 136 iscoaxially aligned with an aperture 124 in boss 122 to enable a pivot pin138 to extend therethrough. See FIG. 4. Such arrangement, whenassembled, permits the end effector 12 to pivot relative to the proximalspine segment 130 about pivot axis A-A.

As indicated above, this embodiment employs bands to articulate the endeffector 12. In particular, the bands 150, 160 may extend distallytoward the articulation pivot 104 as shown in FIGS. 2 and 3. Band 150may extend through the proximal closure tube segment 190 along its leftside where it is routed around band member 160 and across to the rightside of the proximal closure tube segment 190. There, the band 150 maybe mechanically coupled to boss 122, for example, at connection point123. Likewise, band 160 may extend through the proximal closure tubesegment 190 along its right side where it is routed around band member150 and across to the left side of the proximal closure tube segment190. There, band 160 may be mechanically coupled to the boss 122 atconnection point 125.

FIG. 3 is a top view of the end effector and spine assembly 102 with theclosure tube assembly 100 depicted in phantom lines. FIG. 4 is a partialcross-sectional side view of the same portion of the instrument 10. Ascan be seen in FIG. 4, bands 150 and 160 are shown offset from oneanother to prevent interference in movement according to onenon-limiting embodiment. For example, band 150 is shown at a lowerposition than band 160. In another non-limiting embodiment, the verticalpositioning of bands 150 and 160 may be reversed. As can also be seen inFIGS. 2 and 3, the band member 150 extends around a pin 140 in the tangportion 134 of the proximal frame segment 130. Likewise, band 160extends around pin 142 in the tang portion 134 of the proximal framesegment 130. See also, FIG. 2.

Band portions 150 and 160 may extend from the boss 122 and along theproximal closure tube segment 190 to the articulation control 200, shownin FIG. 5. The articulation control 200 may include an articulationslide 202, a frame 204 and an enclosure 206. Band portions 150, 160 maypass through the articulation slide 202 by way of slot 208 or otheraperture, although it will be appreciated that the band portions 150,160 may be coupled to the slide 202 by any suitable means. Thearticulation slide 202 may be one piece, as shown in FIG. 5, or may inone non-limiting embodiment, include two pieces with an interfacebetween the two pieces defining the slot 208. In one non-limitingembodiment, the articulation slide 202 may include multiple slots, forexample, with each slot corresponding to one of band portions 150, 160.Enclosure 206 may cover the various components of the control 200 toprevent debris from entering.

In various embodiments, band portions 150, 160 may be anchored to theframe 204 at connection points 210, 212 proximally located from the slot208. The non-limiting embodiment of FIG. 5 shows that the band portions150, 160 are pre-bent from connection points 210, 212 to the slot 208located near the longitudinal axis of the proximal closure tube segment190. It will be appreciated that band portions 150, 160 may be anchoredanywhere in the instrument 10 located proximally from the slot 208,including the handle assembly 300.

In use, the embodiment of FIG. 2 may have an unarticulated position asshown in FIG. 3. The articulation control 200 and bands 150, 160 areshown in a centered position roughly at the longitudinal axis of theshaft assembly 100. Accordingly, the end effector 12 is in a neutral orunarticulated position. In FIG. 6, the articulation control 200 is shownwith the articulation slide 202 pushed through the articulation frame tothe right side of the shaft assembly 100. Accordingly, bands 150, 160are bent toward the right side of the shaft assembly 100. It can be seenthat the bending of band 150 to the right exerts a laterally directedforce on the boss 122 that is offset from the boss's 122 pivot point.This offset force causes the boss 122 to rotate about articulation pivot104, in turn causing the end effector 12 to pivot to the right as shown.It will be appreciated that pushing the articulation slide 202 to theleft side of the shaft assembly 100 may exert a laterally directed forceon bands 150, 160, bending both bands 150, 160 toward the left side ofthe shaft assembly 100. The bending of band 160 then exerts a laterallydirected force on boss 122, which as above, is offset from the boss's122 pivot point. This, in turn, causes the boss 122 to rotate about thearticulation pivot causing the end effector 12 to pivot to the left.

In various embodiments, the shaft assembly 100 is comprised of a closuretube assembly 170 that is received on the spine assembly 102. See FIG.2. The closure tube assembly 170 comprises a distal closure tube segment180 and a proximal closure tube segment 190. The distal closure tubesegment 180 and the proximal closure tube segment 190 may be fabricatedfrom a polymer or other suitable material. The proximal closure tubesegment 190 is hollow and has an axial passage 191 extendingtherethrough that is sized to receive a portion of the spine assembly102 therein.

In the embodiment depicted in FIGS. 2 and 4, a double pivot closurejoint 172 is employed. It will be appreciated that the invention is notlimited to a double pivot closure joint design and may include anysuitable closure tube or sleeve, or no closure tube or sleeve at all.With particular reference to FIG. 4, the distal closure tube segment 180has upper and lower proximally projecting tangs 182, 184. The distalclosure tube segment 180 further includes a horseshoe aperture 185 andtab 186 for engaging the anvil open/closing tab 46 on the anvil 40 tocause the anvil 40 to pivot between open and closed positions as will bediscussed in further detail below. See FIG. 2.

The proximal closure tube segment 190 is similarly provided with adistally extending upper tang 192 and a distally extending lower tang194. An upper double pivot link 174 includes upwardly projecting distaland proximal pivot pins 175, 176 that engage respectively an upperdistal pin hole 183 in the upper proximally projecting tang 182 and anupper proximal pin hole 193 in the upper distally projecting tang 192.The joint arrangement further includes a lower double pivot link 177that has downwardly projecting distal and proximal pivot pins 178, 179(not shown in FIG. 2, but see FIG. 4) that engage respectively a lowerdistal pin hole 187 in the lower proximally projecting tang 184 and alower proximal pin hole 195 in the lower distally projecting tang 194.

In use, the closure tube assembly 170 is translated distally to closethe anvil 40, for example, in response to the actuation of the closuretrigger 302. The anvil 40 is closed by distally translating the closuretube assembly 170 on the spine assembly 102, causing the back of thehorseshoe aperture 185 to strike the open/closing tab 46 on the anvil 40and cause it to pivot to the closed position. To open the anvil 40, theclosure tube assembly 170 is axially moved in the proximal direction onthe spine assembly 102 causing the tab 186 to contact and push againstthe open/closing tab 46 to pivot the anvil 40 to the opened position.

FIG. 7 illustrates an exploded assembly view of a non-limiting handleassembly 300 of various embodiments of the present invention. In theembodiment depicted in FIG. 7, the handle assembly has a “pistol grip”configuration and is formed from a right hand case member 320 and a lefthanded case member 330 that are molded or otherwise fabricated from apolymer or other suitable material and are designed to mate together.Such case members 320 and 330 may be attached together by snap features,pegs and sockets molded or otherwise formed therein and/or by adhesive,screws, bolts, clips, etc. The upper portion 322 of the right hand casemember 320 mates with a corresponding upper portion 323 of the left handcase member 330 to form a primary housing portion designated as 340.Similarly, the lower grip portion 324 of the right hand case member 320mates with the lower grip portion 334 of the left hand case member toform a grip portion generally designated as 342. In the embodimentdepicted in FIG. 7, the entire grip portion 342 is integral with theprimary housing portion 340. Such arrangement may be particularlywell-suited for applications wherein a source of pressurized gas ispermanently installed within the grip portion 342. Such arrangement isalso suited for use with sources of pressurized gas that are external tothe handle assembly 300 and plugged into the control components housedtherein through a port or ports in the housing assembly. In otherembodiments, as will be described in further detail below, the gripportion 342 is detachable from the primary housing portion 340. As willbe appreciated as the present Detailed Description proceeds, sucharrangement provides a myriad of benefits and advantages. Those ofordinary skill in the art will readily appreciate, however, that thehandle assembly 300 may be provided in a variety of different shapes andsizes.

For the purposes of clarity, FIG. 7 only illustrates the componentsemployed to control the axial movement of the closure tube assembly 170which ultimately controls the opening and closing of the anvil 40. Ascan be seen in that Figure, a closure shuttle 400 that is coupled to theclosure trigger 302 by a linkage assembly 430 is supported within theprimary housing portion 340. Closure shuttle 400 may also be fabricatedin two pieces 402, 404 that are molded or otherwise fabricated from apolymer or other suitable material and are designed to mate together.For example, in the embodiment illustrated in FIG. 7, the right handportion 402 may be provided with fastener posts 403 that are designed tobe received within corresponding sockets (not shown) in the left handportion 404. The right and left hand portions 402, 404 may be otherwiseretained together by snap members and/or adhesive and/or bolts, screws,clips, etc. As can be seen in that Figure, a retention groove 196 isprovided in the proximal end of the proximal closure tube segment 190.The right hand portion 402 of the closure shuttle 400 has a rightretention flange segment 405 that is adapted to cooperate with a leftretention flange segment (not shown) on the left hand portion 404 of theclosure shuttle 400 to form a retention flange assembly that extendsinto the retention groove 196 in the proximal closure tube segment 190.

As can also be seen in FIG. 7, a right spine assembly retention peg 326protrudes inward from the right hand case member 320. Such peg 326protrudes into an elongated slot or window 406 in the right hand portion402 of the closure shuttle 400. A similar closure shuttle Retention peg(not shown) protrudes inward from the left hand case member 330 to bereceived in another window or slot 408 provided in the left hand sideportion 404 of the closure shuttle 400. The retention pegs serve tonon-movably affix the proximal end of the proximal spine segment 130(not shown in FIG. 7) to the handle assembly 300 while permitting theclosure shuttle 400 to move axially relative thereto. The retention pegsmay be mechanically attached to the proximal end of the proximal spinesegment 130 by, for example, bolts, screws, adhesive, snap features,etc. In addition, the closure shuttle 400 is provided with laterallyextending guide 410, 411. Rail 410 is configured to be slidably receivedwithin rail guide 328 the right hand case member 320 and rail 411 isconfigured to be slidably received within a rail guide (not shown) inleft hand case member 330.

Axial movement of the closure shuttle 400 and closure tube assembly 170in the distal direction (arrow “C”) is created by moving the closuretrigger 302 toward the grip portion 342 of the handle assembly 300 andaxial movement of the closure shuttle 400 in the proximal direction(arrow “D”) is created by moving the closure trigger 302 away from thegrip portion 342. In various embodiments, the closure shuttle 400 isprovided with a connector tab 412 that facilitates the attachment of theclosure linkage assembly 430 thereto. See FIGS. 8 and 9. The closurelinkage assembly 430 includes a yoke portion 432 that is pivotallypinned to the connector tab 412 by a pin 414. The closure linkageassembly 430 further has a closure arm 434 that is pivotally pinned to ayoke assembly 304 formed on the closure trigger 302 by a closure pin 436as illustrated in FIG. 7. The closure trigger 302 is pivotally mountedwithin the handle assembly 300 by a pivot pin 306 that extends betweenthe right hand case member 320 and the left hand case member 330.

When the clinician desires to close the anvil 40 to clamp tissue withinthe end effector 12, the clinician draws the closure trigger 302 towardthe grip portion 342. As the clinician draws the closure trigger 302toward the grip portion 342, the closure linkage assembly 430 moves theclosure shuttle 400 in the distal “C” direction until the closurelinkage assembly 430 moves into the locked position illustrated in FIG.8. When in that position, the linkage assembly 430 will tend to retainthe closure shuttle 400 in that locked position. As the closure shuttle400 is moved to the locked position, the closure tube assembly 170 ismoved distally on the spine assembly 102 causing the closure/opening tab46 on the anvil 40 to be contacted by the proximal end of the horseshoeaperture 185 in the distal closure tube segment 180 to thereby pivot theanvil 40 to the closed (clamped) position.

In various embodiments, to further retain the closure shuttle 400 in theclosed position, the closure trigger 302 may be provided with areleasable locking mechanism 301 that is adapted to engage the gripportion 342 and releasably retain the closure trigger 302 in the lockedposition. Other locking devices may also be used to releasably retainthe closure shuttle 400 in the locked position. In the embodimentdepicted in FIGS. 8, 8A, 8B, and 9, the closure trigger 302 includes aflexible longitudinal arm 303 that includes a lateral pin 305 extendingtherefrom. The arm 303 and pin 305 may be made from molded plastic, forexample. The pistol grip portion 342 of the handle assembly 300 includesan opening 350 with a laterally extending wedge 352 disposed therein.When the closure trigger 302 is retracted, the pin 305 engages the wedge352, and the pin 305 is forced downward (i.e., the arm 303 is rotatedCW) by the lower surface 354 of the wedge 352. When the pin 305 fullypasses the lower surface 354, the CW force on the arm 303 is removed,and the pin 305 is rotated CCW such that the pin 305 comes to rest in anotch 356 behind the wedge 352 thereby locking the closure trigger 302.The pin 305 is further held in place in the locked position by aflexible stop 358 extending from the wedge 352.

To unlock the closure trigger 302, the operator may further squeeze theclosure trigger 302, causing the pin 305 to engage a sloped back wall359 of the opening 350, forcing the pin 305 upward past the flexiblestop 358. The pin 305 is then free to travel out an upper channel in theopening 360 such that the closure trigger 302 is no longer locked to thepistol grip portion 342. Further details of such arrangement may befound in U.S. patent application Ser. No. 11/344,020, filed Jan. 31,2006 ,U.S. Patent Publication No. US-2007-0175960 A1 and entitledSurgical Instrument Having A Removable Battery to Shelton, IV et al.,the relevant portions of which are herein incorporated by reference.Other releasable locking arrangements could also be employed.

In various embodiments of the present invention, the knife assembly 30may have a substantially rigid piston bar portion 35 protrudingtherefrom or otherwise attached thereto that is part of a drive member500 that is operably supported by the distal spine segment 110 andconfigured to apply at least two actuation motions (e.g., firing motionand retraction motion) to the knife assembly 30. In the embodimentsdepicted in FIGS. 3, 4, 10, and 11, the drive member 500 comprises a twostage pneumatically-actuated cylinder assembly 501. The knife assembly30 may comprise a unitary component or it may be provided in multiplepieces to facilitate easier assembly of the instrument 10. For example,as shown in FIGS. 10 and 11, the knife bar assembly 30 comprise a distalportion 31 that contains the upper pins 32, the cap 34, the middle pins36 and the knife 38. Distal portion 31 may be provided with an aperture33 therein sized to receive a protrusion 37 provided on the distal endof the piston bar portion 35. The protrusion 37 may be frictionallyreceived within the aperture 33 and/or retained therein by adhesive,welding, etc.

The cylinder assembly 501 comprises a first cylinder housing 510 thathas a first closed proximal end 512 and a first open distal end 514 thatopens into a first axial passage 516 within the first cylinder housing510. The cylinder assembly 501 also comprises a second cylinder housing520 that has a second proximal end 522 and a second open distal end 524that opens into a second axial passage 526. The second closed proximalend 522 has a first piston head 528 formed thereon that is sizedrelative to the first axial passage 516 to create a substantiallyairtight sliding seal with the first wall 511 of the first cylinderhousing 510 to define a first cylinder area 515 between the distal sideof the first proximal end 512 and the proximal side of the first pistonhead 528. The first distal end 514 of the first cylinder housing 510further has an inwardly extending first flange 517 formed thereon forestablishing a substantially airtight sliding seal with the outer wallsurface of the second cylinder housing 520 to define a second cylinderarea 518 between the proximal side of the first flange 517 and thedistal side of the first piston head 528.

A first passage 527 is provided through the first piston head 528. Ascan also be seen in FIGS. 10 and 11, the proximal end of the piston bar35 extends through the second open distal end 524 of the second cylinderhousing 520 and into second axial passage 526. A second piston head 530is formed on or otherwise attached to the proximal end of the piston bar35. The second piston head 530 is sized relative to the second axialpassage 526 to create a substantially airtight sliding seal with asecond wall 521 of the second cylinder housing 520 to define a thirdcylinder area 532. The second distal end 524 of the second cylinderhousing 520 further has an inwardly extending second flange 525 formedthereon for establishing a substantially airtight sliding seal with thepiston bar 35 to define a fourth cylinder area 534 between the proximalside of the second flange 525 and the distal side of the second pistonhead 530.

As can be seen in FIGS. 3 and 4, the cylinder assembly 501 is mountedwithin the distal spine segment 110. In various embodiments, a pair oftrunions 519 are provided on the proximal end of the first cylinderhousing 510. The trunions 519 are received within trunion bores 119 inthe distal spine segment 110 to enable the cylinder assembly 501 topivot within the distal spine segment 110 about a pivot axis B-B. SeeFIG. 3. A first supply line or supply conduit 540 extends from adirectional control valve 610 in the handle assembly 300 (FIGS. 8 and 9)through the proximal closure tube segment 190 to be coupled to the firstproximal end 512 of the first cylinder housing 510 to supply pressurizedgas through a first supply port 513 or opening in the first proximal end512 of the first cylinder housing 510. See FIGS. 10 and 11. In addition,a second supply line 542 extends from the directional control valve 610through the proximal closure tube segment 190 and is connected to thefirst cylinder housing 510 adjacent the distal end 514 thereof to supplypressurized gas into the second cylinder area 518 through a second port529.

With reference to FIGS. 8-11, the extension and retraction of the firingmechanism or knife assembly 30 will now be explained. As can be seen inFIGS. 8 and 9, the supply lines 540 and 542 are coupled to aconventional directional valve 610 which is part of an actuator system600 housed within the handle housing 350. In various embodiments, thedirectional valve 610 may be shifted manually between forward (extend)and reverse (retract) positions by a selector switch 612 or push buttonsthat are accessible through the handle housing 350. See FIG. 1. In theembodiment depicted in FIGS. 8 and 9, a removable source 620 ofpressurized gas is employed. As will be further discussed in detailbelow, such source of pressurized gas comprises a cylinder 622 that maybe rechargeable with a preferred pressurized gas. Those of ordinaryskill in the art will appreciate, however, thatnonreplaceable/rechargeable sources (cylinders) of pressurized gas couldalso be effectively employed. Still in other embodiments, the handleassembly 300 may be provided with a port 616 for supplying pressurizedgas from an external source 618 of pressurized gas. For example, theinstrument 10 could be coupled to the facility's compressed air supply618 through a flexible supply line 617. See FIG. 8B.

The unique and novel aspects of the removable/rechargeable cylinder 622will be discussed in further detail below. However, for the purpose ofexplaining the extension and retraction of the piston bar 35 and knifeassembly 30, it can be seen that pressurized gas flows from the cylinder622 (or external pressure source 618) through a supply line 650 into avariable force actuator that may comprise a conventional rate valve 660.As can most particularly be seen in FIGS. 9 and 55, the rate valve 660is coupled to a supply linkage 662 that is attached to an activationtrigger 670. As used herein, the term “variable force actuationassembly” at least comprises the rate valve 660 and the activationtrigger 670 and their respective equivalent structures. In variousembodiments, activation trigger 670 is supported adjacent the firingtrigger 310 that is pivotally coupled to the handle assembly 300 by apivot pin 370 that extends between the right hand case member 320 andleft hand case member 330. Squeezing the activation trigger 670 inwardtowards the firing trigger 310 causes the rate valve 660 to increase theflow rate of the pressurized gas flowing from the cylinder 622 into asupply line 680 coupled to the directional valve 610. Depending upon theposition of the directional valve 610, the pressurized gas will eitherflow into supply line 540 or 542. For example, when the directionalvalve 610 is actuated by the clinician to fire the knife assembly 30,pressurized gas is permitted to flow through the supply line 540 intothe first cylinder area 515 through the first opening 527 in the firstpiston head 528 and into the third cylinder area 532 upon actuation ofactivation trigger 670. As the pressurized gas enters the third cylinderarea 532, the second piston head 530 forces the piston bar 35 distally.Gas located in the fourth cylinder area vents therefrom through exhaustopening 523 in the second cylinder housing 520. Similarly, the gascontained in the second cylinder area 518 is permitted to vent therefromthrough second opening 529 into the second supply line 542. The secondsupply line 542 carries the vented gas to the directional valve 610wherein it is ultimately vented therefrom. Continued application ofpressurized gas to the first cylinder area 515 and the third cylinderarea 532 causes the knife assembly 30 to be fully extended through theend effector 12. As the knife assembly 30 passes through the endeffector 12, it severs the tissue clamped therein and fires the staples70 in the staple cartridge 50 (drives the staples into forming contactwith the lower surface of the anvil 40). Once the knife assembly 30 hasbeen advanced to its distal-most position in the end effector 12, theclinician discontinues the application of pressurized gas by releasingthe activation trigger 670.

To retract the firing mechanism or knife assembly 30, the clinicianmanually moves the selector switch 612 or appropriate button foradjusting the directional valve 610 to the retract position and beginsto squeeze the activation trigger 670 which causes the pressurized gasto flow into the second supply line 542. Gas flowing through the secondsupply line 542 enters the second cylinder area 518 which causes thesecond cylinder housing 520 to retract proximally into the firstcylinder housing 510. Gas in the first cylinder area 515 is permitted tovent through the first supply opening 513 into the first supply line540. Gas passing through the first supply line 540 enters thedirectional valve 610 wherein it is vented therefrom. Once thepressurized gas entering the second cylinder area 518 has caused thesecond cylinder housing 520 to retract into the first cylinder housing510 as shown in FIG. 10, gas passing through the second opening 529 isnow able to pass through the exhaust opening 523 in the first cylinderhousing 510 and into the fourth cylinder area 534. As pressurized gasenters the fourth cylinder area 534, the second piston head 530 drawsthe piston bar 35 proximally into the second cylinder housing 520. Gasin the third cylinder area 532 passes through the first opening 527 intothe first cylinder area 515 from which it is vented in the mannerdescribed above.

The variable force actuator in the form of rate valve 660 of variousembodiments of the present invention may employ springs or other biasingmeans (not shown) to bias the rate valve 660 to an unactuated position.When in the unactuated position, the rate valve 660 may be configured toprevent any flow of gas from the sources of gas 620 or 618 through anorifice (not shown) within the valve 660. Thus, when the actuatortrigger 670 is in the unactuated position, the device is essentiallyoff.

In the embodiments described above, the rate valve 660 may bemechanically coupled to the activation trigger 670 by the supply linkagearm 662 such that, as the clinician squeezes the activation trigger 670inward toward the firing trigger 310, the linkage arm 662 causes therate valve 660 to permit the flow rate of the gas to increase throughthe valve 660. Thus, quickly squeezing the activation trigger 670 maycause the firing rate of the device to increase and slowing the ratethat the activation trigger 670 is squeezed slows the firing rate. Thus,the amount of gas flow permitted through the rate valve 660 can besubstantially proportionate to the amount of manual force applied to theactivation trigger 670.

In other embodiments, the rate valve 660 may be electronicallycontrolled such that upon actuation of the activation trigger, the ratevalve 660 digitally spurts gas therefrom. The rate valve 660 dischargesa small amount of gas in a pulse manner and the harder that theactivation trigger 670 is squeezed, the closer the pulses will be. Sucharrangement serves to selectively regulate the volume of gas employed toactuate the device.

Also, in still other embodiments, the actuation mechanism may comprisesa different type of mechanism that is not pivotally supported relativeto the handle assembly as is the activation trigger 670. For example,the activation trigger could comprises a spring actuated slide switch,etc. Accordingly, the protection afforded to those embodiments of thepresent invention should not be solely limited to embodiments employinga pivoting actuated trigger.

Also in various embodiments, a pressure gage 541 may be fluidicallycoupled to supply line 540 as shown in FIGS. 8 and 8A. A window 543 maybe provided through a corresponding portion of the handle assembly 300to enable the clinician to view the gage 541 or other arrangements maybe employed to enable the clinician to view the gage 541 during use. SeeFIG. 7. In various embodiments, the pressure gage 541 may comprise anelectronically powered gage or a dial gage. In these non-limitingembodiments, the gage 541 provides a means for providing feedback on theforces encountered during the firing stroke. Those of ordinary skill inthe art will understand that, in certain non-limiting embodiments, theforce necessary to actuate the firing mechanism is directlyproportionate to the pressure in the cylinder assembly 501. If thoseforces are small, then the cylinder assembly 501 does not require largepressures to be actuated. On the other hand, if the forces needed toactuate the cylinder assembly 501 are high, more gas will have to bereleased into the cylinder assembly 501 increasing the pressure thereinto fully actuate the firing mechanism. The pressure gage 541 serves toprovide the clinician with a proportionate reading to the forces beingexperienced by the end effector.

In other various embodiments, an audible outlet 545 may be provided inthe supply line 540 as shown in FIG. 8C. Such audible outlet permits asmall amount of gas to be released from the supply line 540. The ensuingwhistle pitch caused from the discharge of that gas would increase asthe pressure forces increased. The clinician can then relate the pitchof the whistle to the forces experienced by the firing mechanism. Thus,such arrangement provides the clinician with an audible feedbackmechanism for monitoring the firing forces being experienced by thedrive system 500 and ultimately the firing mechanism.

Various non-limiting embodiments may also be provided with means forautomatically notifying the clinician when the firing mechanism hasreached the end of the firing stroke. For example, as shown in FIG. 4, alimit switch 546 may be provided within the distal spine segment 110 fordetecting an activation member 547 embedded into or otherwise attachedto the firing rod 35 as shown in FIG. 11. The activation member 547 isso located such that when the firing bar 35 and firing mechanism reachesthe end of the firing stroke, the activation member 547 is detected bythe limit switch 546 which may be electrically coupled to thedirectional control valve 610 for transmitting an appropriate signalthereto. Upon receipt of such signal, the directional control valve 610may be configured to automatically shift to the retract position and topermit the firing mechanism to be retracted. In addition, the limitswitch 546 may be coupled to an indication member generally designatedas 549 in FIG. 8. In various embodiments, the indication member mayprovide the clinician with an audible signal, a visual signal or acombination of audible and visual signals indicating that the firingmechanism has reached the end of the firing stroke. For example, theindication member may comprise a sound generating device, an led, avibration generating device, etc. or a combination of such devices. Thelimit switch and related control components may be powered by a battery(not shown) supported in the housing assembly 300 or it may be providedwith electrical power from an external source of electrical power. Thus,various non-limiting embodiments of the present invention may beprovided with a means for providing the clinician with a visual and/oraudible signal indicating that the firing mechanism has reached the endof the firing stroke and/or a means for automatically pneumaticallyretracting the firing mechanism to the unactuated position.

As can be seen in FIGS. 4, 10, and 11, a locking protrusion 39 may beformed on the bottom of the piston bar 35. When the knife assembly 30 isin the fully retracted position as shown in FIG. 4, the arm 118 of thelocking spring 112 applies a biasing force to the distal end of thecylinder assembly 501. Because the cylinder assembly 501 is pivotallymounted within the distal spine segment 110 by trunions 519, the distalend of the cylinder assembly 501 pivots downwardly within the distalspine segment 110 and further causes the locking protrusion 39 on thepiston bar 35 to drop into a locking opening 21 in the elongate channel20. Such arrangement serves to lock the knife assembly 30 in theretracted position by virtue of the frictional engagement of the lockingprotrusion 39 with the portions of the elongate channel 20 defining thelocking opening therein. As can be seen in FIGS. 10 and 11, the lockingprotrusion 39 has a proximal ramp surface 39′ and a distal ramp surface39″ to enable the locking protrusion to easily enter and exit thelocking opening in the elongate channel 20. Those of ordinary skill inthe art will readily appreciate that other knife bar lockingarrangements may be successfully employed without departing from thespirit and scope of the present invention.

FIGS. 12-16A illustrate another embodiment of the present inventionwherein the drive member 500 comprises a cylinder assembly 800 that issimilar in construction as cylinder assembly 501 described above, exceptfor the differences noted below. For example, in this embodiment,springs 850, 852 are employed to retract the piston bar 35. As can beseen in FIGS. 12 and 13, the cylinder assembly 800 includes a firsthousing 810 that has a first closed end 812 and a first supply port 813therethrough. A first supply line 840 is attached to the first closedend 812 to supply pressurized gas through the first supply port 813. Inthis embodiment, the first cylinder housing 810 lacks the second opening529 that was described in connection with various embodiments describedabove. A second cylinder housing 820 is slidably received in the firstcylinder housing 810 and has a second closed proximal end 822 that has afirst piston head 828 formed thereon. A first cylinder area 815 isdefined between the first closed end 812 and the first piston head 828.A first retraction spring 850 is provided between the first piston head828 and a first flange 817 formed on the distal end of the firstcylinder housing 810. The first retraction spring 850 serves to bias thesecond cylinder housing 820 into the retracted position in the firstcylinder 810 as shown in FIG. 12. The piston bar 35 has a stepped end35′ that is sized to enter the second distal end 824 of the secondcylinder housing 820. A second flange 825 is formed on the second distalend 824 to achieve a substantially sliding seal with the stepped portion35′ of the piston bar 35. A second piston head 830 is provided on theproximal end of the stepped piston bar section 35′ to define a thirdcylinder area 832 between the second piston head 830 and the firstpiston head 828. A first opening 827 is provide through the first pistonhead 828 to enable air to pass between the first cylinder area 815 andthe third cylinder area 832. A second retraction spring 852 is providedbetween the second flange 825 and the second piston head 830 as shown inFIG. 12 to bias the second piston head 830 and stepped piston bar 35′ tothe fully retracted position within the second cylinder housing 820 asshown in FIG. 12.

This embodiment of the present invention may be operated as follows. Ascan be seen in FIG. 16, the handle assembly 300 is provided with areplaceable source 620 of pressurized gas as was discussed above.However, those of ordinary skill in the art will appreciate thatnonreplaceable sources (cylinders) of pressurized gas could also beeffectively employed. Still in other embodiments, the handle assembly300 may be provided with a port 616 for facilitating attachment of thedirectional control valve 610 and related components to an externalsource of pressurized gas 618. See FIG. 16A. For example, the instrument10 could be coupled to the facility's compressed air line through aflexible supply line 617.

To operate the instrument, the clinician moves the direction controlvalve selector switch 612 (FIG. 1) or push buttons to the forward(extend) position and begins to squeeze the activation trigger 670 (FIG.16) which permits the pressurized gas to flow from the cylinder 622 (orexternal source 618) through the supply line 680 through the directionalcontrol valve 610 and into the supply line 840. The pressurized gasflows from the first supply line 840 through the first supply port 813into the first cylinder area 815, through the first opening 827 and intothe third cylinder area 832. Gas entering the third cylinder area 832causes the second piston head 830 and the stepped portion 35′ of thepiston bar 35 to move distally. After the second piston head 830 hasmoved to a fully extended position (FIG. 13), gas continuing to enterthe first cylinder area 815 biases the second housing 820 to its fullyextended position. Once the knife assembly 30 has been advanced to itsdistal-most position in the end effector 12, the clinician discontinuesthe application of pressurized gas by releasing the activation trigger670.

To retract the firing mechanism or knife assembly 30, the clinician 30moves the directional valve selector switch 612 to the reverse (retract)position wherein the first supply line 840 is connected to a vent in thedirectional valve 610. Gas in the third cylinder area 832 and the firstcylinder area 815 is permitted to exit through the first supply port 813into the supply line 840 and is ultimately vented through thedirectional valve 610. As the gas exits the third cylinder area 832, thesecond retract spring 852 retracts the stepped portion 35′ of the pistonbar 35 into the second cylinder housing 820. Likewise, as the gas existsthe first cylinder area 815, the first retraction spring 850 biases thesecond cylinder housing 520 into the first cylinder housing 810.

Also in this embodiment, a pressure gage 541 may be fluidically coupledto supply line 840 as shown in FIGS. 16 and 16A which can function inthe manner described above and serves to provide the clinician with aproportionate reading to the forces being experienced by the endeffector. In other various embodiments, an audible outlet 545 may beprovided in the supply line 840 as shown in FIG. 16B which can functionin the manner described above to provide the clinician with an audiblefeedback mechanism for monitoring the firing forces being experienced bythe drive system 500 and ultimately the firing mechanism. In otheralternative embodiments, a limit switch 546 (FIG. 15) may be providedwithin the distal spine segment 110 for detecting an activation member547 (FIGS. 12 and 13) embedded into the firing rod 35 for automaticallycontrolling the directional switch 610 and/or providing visual and oraudible signals indicating that the firing mechanism has reached the endof the firing stroke.

FIGS. 17-21A illustrate yet another embodiment of the present inventionwherein the drive member 500 comprises a bellows assembly 900. Thebellows assembly 900 may have a distal end 902 (FIG. 20) that isattached to distal portion 31 of the knife bar assembly 30. The distalend 902 has a protrusion 904 formed thereon that sized to be received inan aperture 33 in portion 31. The protrusion 904 may be frictionallyreceived within the aperture 33 and/or retained therein by adhesive,welding, etc. The distal portion 31 may be constructed and configured aswas described in detail above.

The bellows assembly 900 further includes an expandable/retractablebellows portion 910 that is sized to extend and retract within a bellowspassage 117 in the distal spine segment as shown in FIG. 18. The bellowsportion 910 may be formed with wire containment rings 912 as shown inFIG. 20 and be attached to a base portion 914 that is non-movablyattached to the distal spine segment 110 or comprises an integralportion of the distal spine segment 110. The base 914 may be attached tothe distal spine segment 110 by adhesive, screws, etc. A supply port 916is provided through the bellows base 914 and a supply line 940 isattached to the supply port 916. The supply line 940 is also coupled tothe directional control valve 610 in the handle assembly 300. See FIGS.21, 21A. The directional control valve 610 also communicates with avacuum port 620 mounted in the handle assembly 300 through a vacuum line922. The vacuum port 620 is attachable to a source of vacuum 630 by, forexample, a flexible line 632. The source of vacuum may be a permanentvacuum supply line in the facility. A flexible vacuum line 632 may beattached from the port 620 to the vacuum source 630 to enable theclinician to freely manipulate the instrument.

This instrument may be provided with the closure tube assembly 170 andclosure trigger 310 arrangements described above. Thus, tissue may beclamped in the end effector 12 in the manner described above. After thetissue has been clamped in the end effector 12, the clinician may firethe instrument as follows. The clinician moves the selector switch 612(FIG. 1) or buttons for the directional control valve 610 to the forward(extend) position and begins to squeeze the activation trigger 670. Asthe activation trigger 670 is squeezed, the rate valve 660 permits thepressurized gas to flow from the pressure source 620 (FIG. 21) or 618(FIG. 21A) to the directional control valve 610. The directional controlvalve 610 permits the pressurized gas to flow through the supply line940 into the bellows 910 causing it to extend distally. As the bellows910 extends distally, it drives the knife assembly 30 through the endeffector 12 severing the tissue clamped therein and driving the staples70 in the staple cartridge 50 into forming contact with the bottomsurface of the anvil 40. After the knife assembly 30 has been driven toits distal-most position in the end effector 12, the clinician releasesthe activation trigger 670. To retract the knife assembly 30, theclinician moves the selector switch 612 for the directional controlvalve 610 to the retract position to thereby permit the source of vacuum630 to be coupled to the supply line 940. The application of the vacuumto the supply line 940 causes the bellows 910 to retract to itsretracted position illustrated in FIG. 18. After the bellows 910 hasbeen fully retracted, the clinician may move the selector switch 612 orbuttons to a position wherein the directional control valve stops theapplication of vacuum to the supply line 940. However, the remainingvacuum within the supply line 940 may serve to retain the bellows 910 inthe retracted position.

In the embodiment depicted in FIG. 21, a removable source 620 ofpressurized gas is employed. As will be further discussed in detailbelow, such source of pressurized gas comprises a cylinder 622 that maybe rechargeable. Those of ordinary skill in the art will appreciate,however, that nonreplaceable/rechargeable sources (cylinders) ofpressurized gas or pressurized fluid could also be effectively employed.Still in other embodiments, the handle assembly 300 may be provided witha port 616 for supplying pressurized gas to an external source ofpressurized gas. For example, the instrument 10 could be coupled to thefacility's compressed air line through a flexible supply line 617. SeeFIG. 21A.

Also in this embodiment, a pressure gage 541 may be fluidically coupledto supply line 940 as shown in FIGS. 21 and 21A which can function inthe manner described above and serves to provide the clinician with aproportionate reading to the forces being experienced by the endeffector. In other various embodiments, an audible outlet 545 may beprovided in the supply line 940 as shown in FIG. 21B which can functionin the manner described above to provide the clinician with an audiblefeedback mechanism for monitoring the firing forces being experienced bythe drive system 500 and ultimately the firing mechanism. In otheralternative embodiments, a limit switch 546 (FIG. 18) may be providedwithin the distal spine segment 110 for detecting an activation member912′(FIG. 20) on the bellows assembly 900 for automatically controllingthe directional switch 610 and/or providing visual and or audiblesignals indicating that the firing mechanism or knife assembly 30 hasreached the end of the firing stroke.

FIGS. 22-27 illustrate a non-articulating disposable end effector 12that employs many of the unique and novel attributes of the embodimentsdescribe above. As can be seen in FIG. 23, this embodiment may employthe end effector 12 and any of the drive members 500 that were describedin detail above. In this embodiment, however, the end effector 12 may bedisposable and attached to a distal shaft assembly 1010 that may bereleasably detachable to a proximal shaft assembly 1020 by a unique andnovel quick disconnect type joint generally designated as 1000. Once theend effector 12 has been used, the end effector 12 and distal shaftassembly 1010 to which it is attached may be detached from the proximalshaft assembly 1020 and, if desired, discarded. A new sterile endeffector 12, complete with its own distal shaft assembly 1010 andcylinder arrangement, may then be attached to the proximal shaftassembly 1020 to complete another surgical procedure. As will beexplained in further detail below, the distal shaft assembly 1010includes a distal spine segment 1110 and a distal closure tube segment1180. The proximal shaft assembly 1020 includes a proximal spine segment1150, a proximal closure tube segment 1190 and a release sleeve 1200.

The distal spine segment 1110 and the proximal spine segment 1150cooperate to form a spine assembly 1030. See FIG. 27 In this embodiment,the distal spine segment 1110 may be substantially identical to thedistal spine segment 110 as was described in detail above, except thattheir respective proximal ends differ. Likewise, the proximal spinesegment 1150 may be substantially identical to the proximal spinesegment 130 as described above, except that its distal end differs toenable the distal spine segment 1110 and proximal spine segment 1150 tobe non-pivotally coupled together. Also in this embodiment, the distalclosure tube segment 1180 may be substantially identical to the distalclosure tube segment 180 described above except that their proximal endsdiffer. Likewise, the proximal closure tube segment 1190 may besubstantially identical to the proximal closure tube segment 190 exceptthat their distal ends differ to enable the distal closure tube segment1180 and proximal closure tube segment 1190 to be non-pivotally attachedto each other.

As can be seen in FIG. 23, a locking spring 112 is mounted in the distalspine segment 1110 as a lockout for the piston bar 35. Distal andproximal square apertures 1111, 1113 are formed on top of the distalspine section 1110 to define a clip bar 1115 therebetween that receivesa top arm 116 of the locking spring 112 whose lower, distally extendedarm 118 asserts a downward force on a distal end of the cylinderassembly as was discussed above. It will be appreciated that variousembodiments may include other types of lockouts or no lockouts at all.

The proximal end 1114 of the distal spine segment 1110 has a distalconnector portion 1116 formed therein. See FIGS. 24 and 27. As can beseen in FIG. 24, the distal connector portion 1116 has a first distalsupply port 1117 that is coupled to first supply line segment 540′. Asecond distal supply port 1120 is provided in the distal connectorportion 1116 and is coupled to a second supply line segment 542′. As canbe seen in FIG. 23, the first supply line segment 540′ is coupled tofirst supply port 513 in the first cylinder housing 510 and the secondsupply line segment 542′ is coupled to the second supply port 529 in thedistal end of the first housing 510. A first supply nozzle portion 1118protrudes in the proximal direction from the first distal supply port1117 as shown. A second supply nozzle portion 1122 protrudes outward inthe proximal direction from the second supply port 1120.

Similarly, the distal end 1152 of the proximal spine segment 1150 has asecond connector portion 1154 that has a first proximal supply port 1156that is coupled to another first supply line segment 540″. The secondconnector portion 1154 further has a second proximal supply port 1160therein that is coupled to another second supply line segment 542″. Thefirst proximal supply port 1156 is configured to removably receive thefirst supply nozzle 1118 therein (FIG. 27) and the second proximalsupply port 1160 is sized to removably receive the second supply nozzle1122 therein. As can be seen in FIGS. 24 and 27, a first O-ring seal1158 is associated with the first proximal supply port 1156 for forminga substantially airtight seal (or fluid-tight) between the first supplyline segment 540′ and the another first supply line segment 540″ whenthe first nozzle 1118 is inserted into the first proximal supply port1156. When coupled together in that manner, the first supply linesegments 540′ and 540″ are joined to form a first supply line 540.Likewise, a second O-ring seal 1162 is associated with the secondproximal supply port 1160 for forming another substantially airtight (orfluid-tight) seal between the second supply line segment 542′ and theanother second supply line segment 542″ when the second supply nozzle1122 is inserted into the second proximal supply port 1160. When coupledtogether in that manner, the second supply line segments 542′ and 542″form a second supply line 542. Those of ordinary skill in the art willunderstand that other detachable coupling arrangements, quick disconnectarrangements may be employed to removably connect the first supply linesegment 540′ with the another first supply line segment 540″ and thesecond supply line segment 542′ with the other second supply linesegment 542″ without departing from the spirit and scope of the presentinvention.

The distal connector portion 1116 and the proximal connector portion1154 may be configured so that they may be coupled together in only oneorientation. For example, as shown in FIG. 24, the distal connectorportion 1116 may be provided with a notched portion 1119 that is adaptedto mate with another notched portion 1155 in the proximal connectorportion 1154 to ensure that the first nozzle 1118 engages first proximalsupply port 1156 and the second nozzle 1122 engages the second proximalsupply port 1160 during installation. Such unique and novel attachmentarrangement prevents the inadvertent attachment of the first nozzle 1118to the second proximal supply port 1160 and the second nozzle 112 to thefirst proximal supply port 1156. Other key-like configurations may beemployed to ensure that the distal connector portion 1116 and theproximal connector portion 1154 are coupled in the proper orientation.

As can also be seen in FIGS. 24 and 27, the distal end 1152 of theproximal spine segment 1150 has a hollow sleeve portion 1170 thatprotrudes distally. Such hollow sleeve portion 1170 is sized to receivethe proximal end 1114 of the distal spine segment 1110 therein. Toreleasably lock the distal spine segment 1110 to the proximal spinesegment 1150, a pair of opposing detent members 1124 are formed on theproximal end 1114 of the distal spine segment 1110. The detents 1124 arelocated on flexible tabs 1126 cut or otherwise formed in the distalspine segment 1110 such that when the proximal end 1114 of the distalspine segment 1110 is inserted into the hollow sleeve portion 1170 ofthe proximal spine segment 1150 and the first nozzle 1118 is sealinglycoupled to the first proximal supply port 1156 and the second nozzle1122 is sealingly coupled to the second proximal supply port 1160, thedetent members 1124 are received in corresponding openings 1172 in thehollow sleeve portion 1170. See FIGS. 24 and 27.

Releasable attachment of the distal closure tube segment 1180 to theproximal closure tube segment 1190 will be described with reference toFIGS. 24-27. As can be seen in those Figures, the proximal end 1182 ofthe distal closure tube segment 1180 has at least two bayonet-typelocking tabs 1184 protruding in a proximal direction therefrom. Eachlocking tab 1184 has a tapered locking wedge 1186 formed thereon thatare sized to be received in corresponding lock openings 1194 in theproximal closure tube segment 1190. When in the position illustrated inFIGS. 26 and 27, the distal spine segment 1110 is locked to the proximalspine segment 1150 to form the spine assembly 1030 and the distalclosure tube segment 1180 is locked to the proximal closure tube segment1190 to form the closure tube assembly 1178. Such arrangement permitsthe closure tube assembly 1178 to move proximally and distally on thespine assembly 1030 to open and close the anvil 40 on the end effector12 in the various manners described above.

To attach the distal shaft assembly 1010 to the proximal shaft assembly1020, the user aligns the proximal end 1012 of the distal shaft assembly1010 with the distal end 1022 of the proximal shaft assembly 1020 asshown in FIG. 24 and then inserts the distal end 1012 into the proximalend 1022. When the detents 1124 are received in the locking openings1172 and the locking wedges 1186 are received in the openings 1194, thedistal shaft assembly 1010 is locked to the proximal shaft assembly1020. The anvil 40 may be closed by moving the closure tube assembly1178 distally by grasping the closure trigger 310 and pivoting it to thegrip portion 342 of the handle assembly 300 in the manners describedabove. The knife bar 30 may be driven by actuating the activationtrigger 670 in the manners described above.

To enable the distal shaft assembly 1010 to be easily detached from theproximal shaft assembly 1020, various embodiments employ a releasesleeve arrangement. In these embodiments, a release sleeve segment 1200is slidably journaled over the proximal spine segment 1150 between theproximal spine segment 1150 and the proximal closure tube segment 1190.In various embodiments, the proximal end of the release sleeve 1200 maybe provided with a release button 1204 that protrudes through acorresponding slot 1196 in the proximal end 1195 of the proximal closuretube segment 1190. See FIGS. 22 and 31. Such arrangement permits therelease sleeve 1200 to be axially moved distally and proximally on theproximal spine segment 1150 without hampering the axial travel of theproximal closure tube segment 1190 on the spine assembly 1030.

As can most particularly be seen in FIG. 27, the distal end 1202 of therelease sleeve 1200 is beveled inward and is oriented such that it isadjacent the two closure tube lock openings 1194 in the proximal closuretube segment 1190. To release the distal shaft assembly 1010 from theproximal shaft assembly 1020, the user moves the release button distallyin slot 1196 to move the release sleeve 1200 distally. As the beveleddistal end 1204 of the release sleeve 1200 contacts the locking wedges1186, the locking wedges 1186 are moved inwardly out of engagement withthe lock openings 1194 in the proximal closure tube segment 1190.Further movement of the release sleeve 1200 in the distal directioncauses a second beveled interior edge 1206 in the release sleeve 1200 tocontact the locking detents 1124 and bias them inwardly out ofengagement with the openings 1172 in the proximal spine segment 1150thereby enabling the distal shaft assembly 1010 to be detached from theproximal spine assembly 1020.

The embodiment depicted in FIGS. 22-28 may be effectively used with acylinder assembly 501 of the type described above. The embodimentdepicted in FIGS. 29 and 30 may be effectively used with the cylinderassembly 800 or the bellows assembly 900 described above. As can be seenin FIGS. 29 and 30, the distal connector portion 1116 only has one port1300 formed therein that is coupled to supply line segment 940′. A firstsupply nozzle 1302 protrudes in the proximal direction from the firstdistal supply port 1300 as shown. Likewise, the connector portion 1154only has one proximal supply port 1306 that is coupled to another firstsupply line segment 940″. The proximal supply port 1306 is configured toremovably receive the first supply nozzle 1302 therein. As can be seenin FIGS. 29 and 30, an O-ring seal 1308 is associated with the proximalsupply port 1306 for forming a substantially airtight seal (orfluid-tight) between the first supply line segment 940′ and the anotherfirst supply line segment 940″ when the supply nozzle 1302 is insertedinto the proximal supply port 1306. When coupled together in thatmanner, the first supply line segments 940′ and 940″ are joined to forma first supply line 940. The supply line 940 can then supply pressurizedgas to the cylinder assembly 800 or the bellows assembly 900 in themanners described above.

FIG. 32 illustrates an alternative articulatable surgical cutting andstapling instrument 2000 that a pneumatically powered articulation jointassembly 2002 that may be employed in connection with the end effector12 and the closure tube assembly 170 described above. This embodimentmay also employ the cylinder assembly 501 (FIG. 10) described above. Ascan be seen in FIGS. 33-35, the joint assembly 2002 includes a spineassembly 2004 that comprises a distal spine segment 2010 has a pivotmember 2014 protruding from its proximal end 2012 thereof. The pivotmember 2014 has an actuator fin 2016 protruding therefrom. As shown inFIG. 35, the cylinder assembly 501 is pivotally mounted within thedistal spine segment 2010 on trunions 519.

The pivot member 2014 is pivotally received within a pivot socket 2034formed on the distal end 2032 of the proximal spine segment 2030. Thepivot member 2014 is free to pivot relative to the proximal spine member2030 about pivot axis E-E. See FIG. 36. As can be seen in FIG. 35, thedistal end 2032 of the proximal spine segment 2030 has a groove 2036formed therein for accommodating a portion of the first supply line 540.Similarly a second groove 2038 is provided in the distal end 2032 of theproximal spine segment 2030 for accommodating the second supply line 542therein. The supply lines 540, 542 pass around the pivot socket 2034 andinto the proximal end 2012 of the distal spine segment 2010 wherein theyare attached to the cylinder assembly 501 in the various mannersdescribed above. Those of ordinary skill in the art will appreciate thata sufficient amount of slack may be provided in the supply lines 540 and542 within the hollow proximal spine segment 2030 to enable the distalspine segment 2010 to freely pivot about the pivot axis E-E relative tothe proximal spine segment 2030. By supporting the supply lines 540, 542in the grooves 2036, 2038, respectively, those supply lines will notinterfere with the axial travel of the closure tube assembly 170relative to the spine assembly 2004.

As can also be seen in FIG. 35, a first vertical supply passage 2040 isprovided in communication with the pivot socket 2034. Similarly, asecond vertical supply passage 2050 is also provided in communicationwith the pivot socket 2034 as shown in FIG. 35. A third supply line 2042extending from a switch assembly 2100 mounted in the handle assembly 300communicates with the first vertical supply passage 2040 and a fourthsupply line 2052 extending from the switch assembly 2100 communicateswith the second vertical passage 2050. To assemble the joint assembly2002, the pivot member 2014 is inserted into the pivot socket 2034 and acover 2060 is attached to the proximal spine segment 2030 as shown withscrews 2062 or other suitable fasteners. Thus, pressurized gas enteringthe first vertical supply passage 2040 from the third supply line 2042will cause the distal spine segment 2010 to pivot about pivot axis E-Ein the “F” direction and pressurized gas entering the second verticalsupply port 2050 from the fourth supply line 2052 will cause the distalspine segment 2010 to pivot relative to the proximal spine segment 2030about the pivot axis E-E in the “G” direction. See FIG. 34.

Referring to FIGS. 37-45, a construction and operation of the switchassembly 2100 of various embodiments will be explained. In variousnon-limiting embodiments, the switch assembly 2100 comprises a switchblock 2110 that has a supply port 2112 therein. The supply port 2112 iscoupled to a supply line 651 for receiving pressurized gas from thesource of pressurized gas 620 (FIG. 44) or 618 (FIG. 45). In particular,a supply line 651 may extend from supply line 650 to port 2112. A switchcavity 2114 is provided in the switch block 2110 and is sized topivotally receive a body portion 2150 of a selector member assembly 2130therein. A pivot rod 2151 protrudes out of the bottom of the bodyportion 2150 to be pivotally seated in pivot hole 2111 in the switchblock 2110. See FIG. 39. Such arrangement permits the selector memberassembly 2130 to be selectively rotated about switch axis H-H. See FIG.38. A pair of O-rings 2152, 2154 or other suitable seal members may beprovided as shown in FIGS. 38 and 39 to establish a substantiallyairtight seal between the body portion 2150 of the selector memberassembly 2130 and the switch block 2110. A stem 2156 protrudes from thebody portion 2150 to receive a selector handle 2158. Rotation of theselector handle 2158 causes the body portion 2150 to rotate within theswitch cavity 2114. As can be seen in FIG. 39, the supply port 2112communicates with a supply passage 2116 in the switch block 2110 thatcommunicates with a header area 2118 also formed in the switch block2110.

The body portion 2150 of the selector member assembly 2130 has a centralsupply port 2160 therethrough that communicates with the header area2118. A third supply passage 2045 is provided in the switch block 2110.See FIG. 40. The third supply passage 2045 extends between the switchcavity 2114 and a third supply port 2044 to which the third supply line2042 is attached. Likewise, a fourth supply passage 2055 is provided inthe switch block 2110 and extends between the switch cavity 2114 and afourth supply port 2054 to which the fourth supply line 2052 isattached. When the selector member assembly 2130 is positioned as shownin FIG. 40, pressurized gas entering the switch block 2110 through thesupply port 2112 into the supply passage 2116 passes into the headerarea 2118 and may flow into the central supply passage 2160. However,the pressurized gas will be blocked at the end of the central supplypassage 2160. Thus, the switch is in the off position in FIG. 40.

To pivot the distal spine segment 2010 to the right (opposite of theposition shown in FIG. 34), the selector member assembly 2130 is pivotedto the position illustrated in FIG. 41. As can be seen in that Figure,pressurized gas entering the switch block 2110 through the supply port2112 through supply passage 2116 and into the header area 2118 istransferred through the central supply port 2160 into the third supplypassage 2045 and into the third supply line 2042. The pressurized gasthen flows into the first vertical supply passage 2040 and contacts theactuator fin 2016 on the pivot member 2014 to force the pivot member2014 in the “F” direction. Pressurized gas on the opposite side of theactuator fin 2016 enters the second vertical passage 2050 and flows intothe fourth supply line 2052. As the pressurized gas enters the fourthport 2054 in the switch block 2110, it flows into the fourth supplypassage 2055 and into a fourth vent passage 2170 in the body portion2150. The fourth vent passage 2170 communicates with a undercut ventarea 2155 in the body portion 2150 of the selector member assembly 2130.See FIG. 43. Thus, the pressurized gas in the fourth supply line 2052 isvented through the fourth vent passage 2170 and out of the switchthrough the undercut vent area 2155.

To pivot the distal spine segment 2010 to the position shown in FIG. 34,the clinician rotates the selector member assembly 2130 such that thecentral supply passage 2160 now extends between the header area 2118 andthe fourth supply passage 2055. Thus, pressurized gas flowing from thesupply line 651 into the supply passage 2116 and into the header area2118 flows through the central supply passage 2160 into the fourthsupply passage 2055. The pressurized gas flows out through the fourthsupply port 2054 and into the fourth supply line 2052. The fourth supplyline 2052 transfers the pressurized gas into the second vertical supplypassage 2050. As the pressurized gas enters the second vertical supplypassage 2050, the actuator fin 2016 pivots the pivot member 2014 in the“G” direction. See FIG. 34. The gas on the opposite side of the actuatorfin 2016 flows through the first vertical supply passage 2040 and intothe third supply line 2042. The gas exits the third supply line 2042into the third supply passage 2045 and flows into a third vent passage2180 provided in the body portion 2150. The third vent passage 2180 isoriented to vent the gas out through the undercut vent area 2155.

Another unique and novel feature of this embodiment, is an automaticneutral feature arrangement that enables the clinician to lock thedistal spine portion 2010 (and end effector 12) in a desired articulatedposition simply by releasing the selector switch handle 2158. Morespecifically, a return spring 2190 configured as shown is mounted in theswitch block 2110 as shown in FIGS. 40, 41, and 43. To retain the spring2190 in the switch block 2110, a pair of opposing bosses 2192, 2194protrude from the bottom surface 2113 of the switch block 2110. Thespring 2190 is retained within slots 2193, 2195 in the bosses 2192,2194, respectively. See FIG. 43. As can be seen in FIG. 43, a return rod2153 protrudes from the body portion 2150 of the selector memberassembly 2130. The return rod 2153 is received between the free ends2196, 2198 of the return spring 2190. FIG. 43 illustrates the bodyportion 2150 in the neutral or closed position.

Thus, when the clinician desires to articulate the end effector 12, heor she rotates the selector handle 2158 to move the body portion 2150 ofthe selector member assembly 2130 in the rotational directioncorresponding to the desired articulation travel. As the clinicianrotates the body portion 2150, it is rotated against the force generatedby one of the free ends 2196, 2198 of the return spring 2190. Once theclinician has articulated the end effector 12 to the desired position,he or she releases the selector handle 2158 and the return spring 2190moves the body portion 2150 to the closed position, which retains theend effector 12 in that position. If the clinician desires to adjust thearticulated position of the end effector 12, he or she merely rotatesthe selector handle 2158 in the desired direction to attain the desiredposition and thereafter releases the handle 2158 to retain the endeffector 12 in that position.

FIG. 44 illustrates the arrangement of the control system componentsused in connection with the switch 2100 for various non-limitingembodiments of the present invention. As can be seen in that Figure, aremovable source 620 of pressurized gas is employed. The gas flowingfrom the source 620 flows through supply line 650 to the rate valve 660and through the supply line 651 to port 2112 in the switch assembly2100. In the embodiments depicted in FIG. 44, the source 620 comprises areplaceable/rechargeable canister 622 that is supported within the gripportion 342 of the housing assembly 300. The cylinder 622 may berechargeable. Those of ordinary skill in the art will appreciate,however, that nonreplaceable/rechargeable sources (cylinders) ofpressurized gas could also be effectively employed. Still in otherembodiments, the handle assembly 300 may be provided with a port 616 forsupplying pressurized gas from an external source 618 of pressurizedgas. For example, the instrument could be coupled to the facility'scompressed air line (not shown) through a flexible supply line 617. SeeFIG. 45.

FIGS. 46-48 illustrate the use of the articulation joint assembly 2002arrangement in connection with a quick disconnect joint 1000′ of thetype and construction described above. In this arrangement, however, atotal of four ports are used. As can be seen in FIG. 47, the distalconnector portion 1116 has a first distal supply port 1117 that iscoupled to first supply line segment 540′. A second distal supply port1120 is provided in the distal connector portion 1116 and is coupled toa second supply line segment 542′. A first supply nozzle portion 1118protrudes in the proximal direction from the first distal supply port1117 as shown. A second supply nozzle portion 1122 protrudes outward inthe proximal direction from the second supply port 1120.

The distal connector portion 1116 further has a third distal supply port1117′ that is coupled to a third supply line segment 2042′. A fourthdistal supply port 1120′ is provided in the distal connector portion1116 and is coupled to a fourth supply line segment 2052′. A thirdsupply nozzle portion 1118′ protrudes in the proximal direction from thethird distal supply port 1117′ as shown. A fourth supply nozzle portion1122′ protrudes outward in the proximal direction from the fourth supplyport 1120′.

Similarly, the distal end 1152 of the proximal spine segment 1150 has asecond connector portion 1154 that has a first proximal supply port 1156that is coupled to another first supply line segment 540″. The secondconnector portion 1154 further has a second proximal supply port 1160therein that is coupled to another second supply line segment 542″. Thefirst proximal supply port 1156 is configured to removably receive thefirst supply nozzle 1118 therein and the second proximal supply port1160 is sized to removably receive the second supply nozzle 1122therein. As can be seen in FIG. 47, a first O-ring seal 1158 isassociated with the first proximal supply port 1156 for forming asubstantially airtight seal (or fluid-tight) between the first supplyline segment 540′ and the another first supply line segment 540″ whenthe first nozzle 1118 is inserted into the first proximal supply port1156. When coupled together in that manner, the first supply linesegments 540′ and 540″ are joined to form a first supply line 540.Likewise, a second O-ring seal 1162 is associated with the secondproximal supply port 1160 for forming another substantially airtight (orfluid-tight) seal between the second supply line segment 542′ and theanother second supply line segment 542″ when the second supply nozzle1122 is inserted into the second proximal supply port 1160. When coupledtogether in that manner, the second supply line segments 542′ and 542″form a second supply line 542.

In addition, the distal end 1152 of the proximal spine segment 1150 hasa second connector portion 1154 that has a third proximal supply port1156′ that is coupled to another third supply line segment 2042″. Thesecond connector portion 1154 further has a fourth proximal supply port1160′ therein that is coupled to another fourth supply line segment2052″. The third proximal supply port 1156′ is configured to removablyreceive the third supply nozzle 1118′ therein and the fourth proximalsupply port 1160′ is sized to removably receive the fourth supply nozzle1122′ therein. As can be seen in FIG. 47, a third O-ring seal 1158′ isassociated with the third proximal supply port 1156′ for forming asubstantially airtight seal (or fluid-tight) between the third supplyline segment 2042′ and the another third supply line segment 2042″ whenthe third nozzle 1118′ is inserted into the third proximal supply port1156′. When coupled together in that manner, the third supply linesegments 2042′ and 2042″ are joined to form a third line 2042. Likewise,a fourth O-ring seal 1162′ is associated with the fourth proximal supplyport 1160′ for forming another substantially airtight (or fluid-tight)seal between the fourth supply line segment 2052′ and the another fourthsupply line segment 2052″ when the fourth supply nozzle 1122′ isinserted into the fourth proximal supply port 1160′. When coupledtogether in that manner, the fourth supply line segments 2052′ and 2052″form a fourth supply line 2052. Those of ordinary skill in the art willunderstand that other detachable coupling arrangements, quick disconnectarrangements may be employed without departing from the spirit and scopeof the present invention.

As indicated above in the Background section hereof, as endocuttersystems became smaller and smaller, the challenges of developing apneumatically powered system that could generate the necessary driveforces became greater. Such problems were somewhat easier to address byusing electric motors to drive rotary drive shafts. Rotary motion canreadily be transmitted over long flexible or articulatable drive shafts.Although tremendous strides have been made in electric motor size andtorque capabilities, the effectiveness of such systems will be limitedby the size of the distal elongated shaft diameter and the size of motorthat can be fitted in that area for the motor to be as close to thestapling mechanism as possible. In many current applications, thedesired size of the shaft diameter prevents the electric motor frombeing located at the distal end of the system while being able toprovide sufficient energy to drive the system.

The following embodiments address such problems and shortcomingsassociated with use of electric drive motors. As will be discussedbelow, these embodiments employ a pneumatically powered motor totransmit rotary power to a rotary driven endocutter. Pneumaticallypowered motors generally produce torques and rotations per minute thatare proportionate to the pressure and volume of the gas transmitted tothe motor. In the non-limiting embodiments depicted in FIGS. 49-56, anarticulated drive shaft assembly is employed to transmit the rotarymotion from the pneumatically powered pneumatically powered motor to theend effector. Those of ordinary skill in the art will understand,however, that the unique and novel aspects of these embodiments of thepresent invention may also be effectively used in connection with otherknown rotary driven end effectors and other surgical instruments thatemploy a flexible drive shaft arrangement for conveying rotary drivemotion to the endocutter. In addition, the unique and novel aspects ofthese embodiments of the present invention may be effectively employedin connection with nonarticulating end effector arrangements.

FIGS. 49-56 illustrate a surgical cutting and stapling instrument 1500of the present invention that employs a rotary driven endocutter 1512. Avariety of rotary driven endocutters and other surgical instrumentsexist. For example, one such rotary endocutter arrangement is disclosedin U.S. patent application Ser. No. 11/343,447, filed Jan. 31, 2006 ,U.S. Patent Publication No. U.S.-2007-017597 A 1 and entitled MotorDriven Surgical Cutting and Fastening Instrument With Adaptive UserFeedback to Shelton, IV et al., the relevant portions of which areherein incorporated by reference. Other examples are disclosed in U.S.patent application Ser. No. 11/475,412 , entitled Manually DrivenSurgical Cutting and fastening Instrument to Shelton, IV et al., filedJun. 27, 2006 , the relevant portions of which are herein incorporatedby reference.

FIG. 50 is an exploded view of the end effector 1512 according tovarious non-limiting embodiments. As shown in the illustratedembodiment, the end effector 1512 may include an elongate channel 1520that is sized to receive a pneumatically operated tool. Thepneumatically operated tool of various non-limiting embodimentscomprises a staple cartridge 50 that operably supports a “firingmechanism” therein. This embodiment includes a wedge sled assembly 1530that carries a knife portion 1538 thereon. The wedge sled assembly 1530is threaded onto a helical drive screw 1560. A bearing 1522, positionedat a distal end 1521 of the elongate channel 1520, receives the helicaldrive screw 1560, allowing the helical drive screw 1560 to freely rotatewith respect to the elongate channel 1520. The helical drive screw 1560may interface with a threaded opening (not shown) of the wedge sledassembly 1530 such that rotation of the drive screw 1560 causes thewedge sled assembly 1530 to translate distally or proximately (dependingon the direction of the rotation) through the elongate channel 1520between a full extended or actuated position wherein the staplessupported in the cartridge have all been fired and a fully retractedposition or unactuated position. Accordingly, when the helical drivescrew 1560 is rotated in one direction, the wedge sled assembly 1530 isdriven distally through the cartridge 50 severing tissue clamped withinthe end effector 1512 and firing the staples within the cartridge 50into forming contact with the bottom surface of an anvil 40 that ispivotally coupled to the elongate channel 1520. The sled portion 1532 ofthe wedge sled assembly 1530 may be made of, for example, plastic, andmay have a sloped distal surfaces 1534. As the wedge sled assembly 1530traverses the elongate channel 1520, the sloped forward surfaces 1534may push up or drive the staples in the staple cartridge 50 through theclamped tissue and against the anvil 40. (not shown in FIG. 52). Theanvil 40 turns the staples, thereby stapling the severed tissue. Whenthe wedge sled assembly 1530 is retracted, the knife portion 1538 andsled portion 1532 may become disengaged, thereby leaving the sledportion 1532 at the distal end of the elongate channel 1520. Those ofordinary skill in the art will appreciate that other pneumaticallyoperated tools with other firing mechanisms may be employed.

FIGS. 51 and 52 illustrate one drive shaft arrangement for transmittingrotational motion to the helical drive screw 1560 from a pneumaticallydriven motor in the handle assembly 300. As can be seen from referenceto FIG. 51, this embodiment may employ a closure tube assembly 170 thatwas described in detail above. The closure tube assembly 170 is slidablyreceived on a spine assembly 1540 that comprises a proximal spinesegment 1542 that rotatably supports a main rotational (or proximate)drive shaft 1544 that communicates with a secondary (or distal) driveshaft 1546 via a bevel gear assembly 1550 that includes gears 1552,1554, 1556. The secondary drive shaft 1546 is connected to a drive gear1548 that engages a proximal drive gear 1562 of the helical drive screw1560. The vertical bevel gear 1552 is pivotally supported in an opening1543 in the distal end of the proximal spine segment 1542. A distalspine segment 1570 may be used to enclose the secondary drive shaft 1546and the drive gears 1548, 1562. Collectively, the main drive shaft 1544,the secondary drive shaft 1546, and the articulation assembly (e.g., thebevel gear assembly 1550) are sometimes referred to herein as the “maindrive shaft assembly.”

As can be seen in FIGS. 53 and 54, various embodiments of the instrument1500 are powered by a source of pneumatic power in the form ofpressurized gas 620. In the embodiments depicted in those FIGS., thesource 620 comprises a replaceable/rechargeable canister 622 that issupported within the grip portion 642 of the housing assembly 300. Thecylinder 622 may be rechargeable. Those of ordinary skill in the artwill appreciate, however, that nonreplaceable/rechargeable sources(cylinders) of pressurized gas could also be effectively employed. Stillin other embodiments, the handle assembly 300 may be provided with aport 616 for supplying pressurized gas from an external source 618 ofpressurized gas. For example, the instrument 1500 could be coupled tothe facility's compressed air line (not shown) through a flexible supplyline 617. See FIG. 53A.

The unique and novel aspects of the removable/rechargeable cylinder 622will be discussed in further detail below. However, for the purpose ofexplaining the drive system for providing rotary motion to the endeffector 1512, it can be seen that pressurized gas flows under pressurefrom the cylinder 622 or external pressure source 618 through a supplyline 650 into a conventional rate valve 660. The rate valve 660 iscoupled to a supply linkage 662 that is attached to an activationtrigger 670. See FIGS. 53 and 55. In various embodiments, activationtrigger 670 is supported adjacent a travel monitoring member or relativeposition firing trigger 310′ that is pivotally coupled to the handleassembly 300 by a pivot pin 370 that extends between the right hand casemember 320 and left hand case member 330. The relative position trigger310′ may be fabricated from plastic or other suitable material and has aportion with a substantially U-shaped cross-section to accommodate theactivation trigger 670 as shown. The clinician can position his or herhand on the grip portion 352 of the housing assembly 300 such that theirlower three fingers are on the relative position trigger 310′ and theirindex finger is on the activation trigger 670. Squeezing the activationtrigger 670 inward towards the relative position trigger 310′ causes therate valve 660 to permit gas to pass under pressure therethrough fromthe source 620 (or 618 in FIG. 53A) into a supply line 680 into thedirectional control valve 1610.

As can be seen in FIG. 56, the directional control valve 1610 has aforward position section 1620, a stop section 1630, and a reversesection 1640. The control valve sections 1620, 1630, 1640 may bemanually shifted by the push buttons 1612 and 1614 that protrude throughthe handle housing 300. See FIGS. 49 and 56. Two supply/exhaust lines1700, 1710 extend from the directional control valve 1610 to aconventional pneumatically powered motor 1730. Thus, when the clinicianshifts the control valve 1610 to the forward position, the forwardpassage 1622 permits the pressurized gas to flow from the supply line680 and into the supply/exhaust line 1700 to cause the pneumaticallydriven motor 1730 to drive the motor drive shaft 1732 in a firstdirection that will, as will be discussed in further detail below,result in the transmission of rotary motion to the drive shaft 1544which will drive the wedge sled assembly 1532 and knife portion 1538distally through the end effector 1512 in a firing stroke. The gasexiting the pneumatically powered motor 1730 through the supply line1710 is exhausted through a vent port 1632. When the control valve 1610is shifted to the reversed position, gas passing through the supply line680 is permitted to flow through the supply line 1710 into thepneumatically powered motor 1730. Gas exiting the pneumatically poweredmotor 1730 through the supply/exhaust line 1700 is exhausted through thevent port 1632. When the control valve is in the stopped position, thesupply line 1680 and the supply/exhaust line 1710 are closed and supplyline 1700 is connected to the vent port 1632. See FIG. 56.

As can further be seen in FIG. 56, the output shaft 1732 of thepneumatically powered motor 1730 may have a first drive gear 1734thereon that is in meshing engagement with a second drive gear 1736 thatis mounted to an input shaft 1738 of a planetary gear assembly 1740. Theplanetary gear assembly 1740 has an output shaft 1742 that is coupled tothe proximal end 1545 of the drive shaft 1544 by a conventional shaftcoupling member 1743 to convey rotary motion thereto. Thus, when thecontrol valve 1610 is shifted to the forward position, the output shaft1732 of the pneumatically powered motor 1730 imparts a rotary motion tothe drive shaft 1544 through gears 1734, 1736 and the planetary gearassembly 1740 to cause the wedge sled assembly 1530 and knife portion1538 to drive through the cartridge 50 severing tissue clamped in theend effector 1512 and driving the staples in the cartridge 50 intoforming contact with the anvil 40. When the control valve 1610 isshifted to the reverse position, the output shaft 1732 of thepneumatically powered motor 1730 imparts an opposite rotary motion tothe drive shaft 1544 to retract the wedge sled assembly 1530 and knifeportion 1538 in a proximal direction back through cartridge 50.

The embodiments depicted in FIGS. 49-56, also have further unique andnovel features that enhance the operability of the instrument andprovide various forms of feedback to the clinician so that the cliniciancan monitor the position of the wedge sled assembly 1530 and knifeportion 1538 within the cartridge 50 as it is advanced distally thereinand also retracted. Turning again to FIG. 56, it can be seen that afeedback gear 1750 is provided on the drive shaft 1544 or on the outputshaft 1742 of the planetary gear assembly 1740. The feedback gear 1750is in meshing contact with a knife position gear 1752 that is mounted ona threaded knife position shaft 1754. The knife position shaft 1754 maybe supported by appropriate bearing arrangements (not shown) thatfacilitate its free rotation therein. A proximal limit switch 1760 isassociated with the proximal end 1756 of the shaft 1754 and a distallimit switch 1770 is associated with the distal end 1758 of the shaft1754. A knife indicator 1780 is threaded onto the knife position shaft1754 for distal and proximal travel thereon. As the drive shaft 1544 isrotated in the direction which causes the wedge sled assembly 1530 andknife portion 1538 to move distally through the cartridge 50, the knifeindicator 1780 also moves proximally towards the distal limit switch1770. The distal limit switch 1770 is oriented such that when the wedgesled 1530 and knife portion 1538 are at the distal-most position, theknife indicator 1789 actuates the distal limit switch 1770. A window isprovided in the left hand case member 330 (or right hand case member 320depending upon the location of the knife position shaft 1754 in thehousing assembly 300) such that the clinician can view the position ofthe knife indicator 1780 to determine the position of the firingmechanism (wedge assembly 1530 and knife portion 1538) within its firingstroke and also provide the clinician with means for monitoring theposition of the wedge assembly 1530 during the retraction stroke.

Also in various embodiments, a distal pilot line 1772 may be providedfrom the supply line 650 to the distal limit switch 1770. A distal limitswitch line 1774 may be provided between the distal limit switch 1770and the directional control valve 1610. Thus, when the wedge sledassembly 1530 and knife portion 1538 have completed the firing strokeand the knife indicator 1780 activates the distal limit switch 1770, thedistal limit switch 1770 permits the gas to flow under pressure from thesupply line 650 to the distal limit switch line 1774 and into thedirectional control valve 1610 which, in various embodiments, causes thedirectional control valve 1610 to automatically shift to the reverseposition and thereby cause the pneumatically powered motor 1730 toreverse and ultimately impart a reversing rotary motion to the driveshaft 1544. As the pneumatically powered motor 1730 reverses the driveshaft 1544, the reverse rotary motion is transmitted to the knifeposition shaft 1754 to thereby drive the knife position indicator 1780back toward the proximal limit switch 1760. A proximal pilot line 1662may also extend between the proximal limit switch 1760 and the supplyline 650 such that when the knife position indicator 1780 actuates theproximal limit switch 1760 (signifying that the wedge sled 1530 andknife portion 1538 has moved to its fully retracted position), theproximal limit switch 1660 then permits gas to flow into a proximallimit switch line 1664 and into the directional control valve 1610 tocause the directional control valve 1610 to automatically shift to thestopped position.

In various embodiments, a first air powered whistle 1790 or othersuitable sound generating device may communicate with the distal limitswitch line 1774 (or distal limit switch 1770) such that when the distallimit switch 1770 is actuated at the end of the firing stroke, airpassing through the distal limit switch line 1774 activates the firstwhistle 1790 to provide the clinician with an audible signal indicatingthat the wedge sled/knife has reached the end of the firing stroke.Likewise, a second air powered whistle 1792 or other suitable soundgenerating device may communicate with the proximal limit switch 1760such that when the proximal limit switch 1760 is actuated at the end ofthe retraction stroke, air passing through the proximal limit switchline 1764 activates the second whistle 1792 to provide the clinicianwith another audible signal indicating that the wedge sled/knife hasreached the end of the retraction stroke. In other embodiments, forexample, battery powered light emitting diodes or other signal devicesmay communicate with the distal and proximal limit switches 1770, 1760to provide the user with another indication when the wedge sled/knifehas reached the end of the firing stroke and/or the retraction stroke.In alternative embodiments, the whistles 1790, 1792 may be replaced withpressure sensors or gages to indicate when the device has reached theend of the firing stroke and/or the retraction stroke.

In the various embodiments depicted in FIGS. 49-56, the pneumaticallydriven motor is supported within the handle assembly 300. In theembodiments depicted in FIGS. 52A and 52B, the pneumatically poweredmotor 1730′ is located within the distal spine section 110. The motordrive shaft 1546 has a drive gear 1548′ thereon that is in meshingengagement with proximal drive gear 1562 of the helical drive screw1560. FIG. 52A depicts such distally mounted pneumatically powered airmotor in connection with an articulation joint 104 as was describedabove. The embodiment depicted in FIG. 52B employs a pneumaticallypowered articulation 2002 joint assembly as was described above. Suchdistally mounted air motor arrangements could also be employed inconnection with surgical instruments that employ other articulatingjoint arrangements or used in connection with instruments wherein theend effector does not articulate relative to the handle assembly orportion of the elongate shaft assembly to which it is attached. Those ofordinary skill in the art will understand that such distally mountedpneumatically powered motor arrangements minimize power losses that maybe encountered through elongated drive shaft arrangements forembodiments wherein the motor is supported in the handle assembly andthe firing and retraction motions must be transmitted through thearticulation joint to the end effector. The embodiments such as thosedepicted in FIGS. 52A and 52B only require two lines 1710 and 1760 topass through the articulation joint to power the motor 1730′. Lines 1710and 1760 may comprise flexible tubing or the like and are less likely tolimit the articulation joints when compared to other arrangements thatrequire one or more drive members to pass through the joint.

Also, various embodiments of the present invention may be constructed toprovide the user with a tactile form of feedback concerning the relativeposition of the instrument's firing components. In some embodiments,this is accomplished by linking the travel monitoring member or relativeposition trigger 310′ to the advancement and retraction motions appliedto the drive shaft or firing mechanism of the device. More particularlyand with reference to FIGS. 53-55, this embodiment may include afeedback linkage assembly 1800 that, in various non-limitingembodiments, may comprise a threaded manual feedback shaft 1801 that isthreadably attached to a nut member 334 that is rotatably mounted to anupper attachment plate portion 332 of the relative position trigger310′. The distal end of the manual feedback shaft 1801 has a universaljoint portion 1802 that supports a manual feedback gear 1804 that is inmeshing engagement with the knife position gear 1752. When thedirectional control valve 1610 is in the forward position, thepneumatically powered motor 1730 drives the drive shaft 1544 such thatthe firing mechanism in the form of a wedge sled 1530 and knife portion1538 is driven distally through the cylinder (firing stroke). Thefeedback gear 1750 drives the knife position gear 1752 which, in turn,drives the manual feedback gear 1804. The manual feedback gear 1804 thenrotates the manual feedback shaft which, by virtue of its threadedengagement with the nut 334, draws the relative position trigger 310′towards the grip portion 342 of the handle assembly 300 therebyproviding the clinician with a “tactile” indication of the advancementof the wedge sled 1530 and knife portion 1538. Those of ordinary skillin the art will understand that if the clinician attempts to pivot therelative position trigger 310′ towards the grip portion 342 of thehandle assembly 300, the manual feedback shaft 1801 and nut 334 willprevent any travel thereof. However, the relative position trigger 310′will automatically pivot in relation to the advancement and retractionof the wedge sled 1530 and knife portion 1538. Such arrangement providesthe clinician with an automatic tactile indication of the advancementand retraction of the wedge sled assembly 1530 and knife portion 1538(firing mechanism) simply by the grasping the relative position trigger310′ throughout the surgical procedure. Thus, the clinician does nothave to look at anything to obtain such feedback. Such arrangementprovides the clinician with a one handed non-visual feedback of theprogress of the firing mechanism between the unactuated position and theactuated position and also when the firing mechanism is traveling backfrom the actuated position to the unactuated position.

Various embodiments may be further provided with another tactilefeedback arrangement, generally designated as 333. For example, as canbe seen in FIGS. 53-56, the upper attachment plate portion 332 of therelative position trigger 310′ may be provided with a series of slots335, detents, grooves, etc. that are designed to interface with a springarm 337 mounted within the handle assembly 300 as the relative positiontrigger 310′ pivots about pin 370 during the firing and retractionstrokes. As the upper attachment plate portion 332 pivots with therelative position trigger 310′, the end of the spring arm 337 drops intoeach successive slot 335 and serves to impart (in series) a force to theupper attachment plate portion 332 which can be felt by the clinicianwhen grasping the relative position trigger 310′. Thus, as the relativeposition trigger 310′ advances, the clinician will be provided with aseries of additional tactile feedback motions corresponding to themovement of the firing mechanism to confirm that the relative positiontrigger 310′ (and ultimately the firing mechanism) are either advancingduring the firing stroke or retracting during the retraction stroke,which ever the case may be. In addition, as the end of the spring arm337 drops into each successive slot, it may create an audible sound,click, etc. to provide the clinician with audible feedback concerningthe movement of the firing mechanism through the firing stroke and theretraction stroke. Thus, this embodiment provides a series (at leasttwo) audible sounds that relate to the movement of the firing mechanismbetween unactuated and actuated positions.

Those of ordinary skill in the art will appreciate that the instrument1500 represents a vast improvement over prior pneumatically poweredendocutter arrangements. For example, various embodiments provide ameans for the clinician to monitor the position of the firing mechanism(wedge sled/knife) as it is being driven through its firing stroke. Insome embodiments, when the wedge sled/knife reaches the end of itsfiring stroke, it is automatically retracted. Once in the fullyretracted position, the control valve may be automatically switched to astopped position thereby discontinuing the supply of air from the source618 or 620 to the pneumatically powered motor 1730. If, however, duringthe activation process, the clinician wishes to stop the advancement ofthe wedge sled/knife distally in the cylinder, he or she can simplymanually switch the control valve 1610 to the reverse position andcontinue to activate the activation trigger 670 to supply pressurizedgas to the pneumatically powered motor 1730 until the wedge sled/knifeis moved to the desired retracted position. Furthermore, the unique andnovel relative position trigger 310′ provides the clinician with manualor tactile feedback that he or she can feel while gripping the relativeposition trigger 310′. Also, the clinician can be provided with audiblesignals when the wedge sled/knife has reached the end of the firingstroke and/or has been fully retracted.

The skilled artisan will also appreciate that the unique and noveladvantages provided by the travel monitoring device may also be attainedwhen employing the drive members 500, 800 or bellows assembly 900 byconnecting each of those drive members to the upper attachment plateportion 332 or other portion of the relative position trigger 310′ by apush/pull flexible cable (not shown) or rigid member (fornon-articulating embodiments) such that the advancement and retractionof those drive members is directly or indirectly linked to the relativeposition trigger 310′. This unique and novel arrangement may also beemployed with the embodiment depicted in FIGS. 70-83 described below.

As indicated above, the feedback linkage assembly 1800 not onlyautomatically moves the relative position trigger 310′ at a rate thatcorresponds to the rate of movement of the firing mechanism so as toprovide the clinician with a means to monitor the progress of the firingmechanism, the feedback linkage assembly 1800 may employ threads orother means that effectively would prevent or greatly limit theclinician from being able to manually pivot the relative positiontrigger 310′. In such non-limiting embodiments, the only time that therelative position trigger 310′ moves is when the feedback linkageassembly moves it. In still other embodiments, the manual movement ofthe relative position trigger 310′ may be prevented by a motor (notshown) or another gas cylinder (not shown) configured to prevent anypivotal travel of the relative position trigger 310′ when actuated. Forexample, the presence of force on the activation trigger 670 activatesthe release of the gas, but until the firing mechanism begins to move,the relative position trigger 310′ would not be allowed to substantiallymove, and should the firing mechanism cease to move, so would motion ofthe relative position trigger 310′.

In other various embodiments, however, the feedback linkage assembly1800 may be so constructed as to provide the clinician with the abilityto assist the drive member in the form of a pneumatically powered motor1740 during the firing stroke so as to add force thereto or to retardadvancement of the firing mechanism if the clinician so desires. Inthese various embodiments, for example, the feedback shaft 1801 may beformed with an acme-type thread or other thread arrangement orconfiguration that would actually permit the clinician to apply pressureto the relative position trigger 310′ and thereby impart a rotationalforce to the shaft 1801 by virtue of its engagement with the nut 334. Byimparting a rotational motion to shaft 1801, the clinician also appliesa rotational force to gear 1804 which is in meshing engagement with gear1750 that is journaled on the drive shaft 1544. Thus, if the firingmechanism encounters resistance, the clinician can apply mechanicallygenerated power to the drive shaft 1544 by squeezing the relativeposition trigger 310′. If the clinician desires to slow down or retardthe movement of the firing mechanism, the clinician can apply force tothe relative portion trigger 310′ which will in turn resist/slowrotation of the shaft 1801 and the gear 1804 and ultimately the rotationof the drive shaft 1544.

Various embodiments described above have been described in connectionwith the use of a material storage member in the form of a removablecylinder 622 for supplying gas under pressure to operate the device. Invarious embodiments, the removable cylinder 622 may initially be filledwith gas under pressure and be rechargeable. In other embodiments, thecylinder may not be refillable. For example, the cylinder 622 maycomprise a conventional disposable cylinder filled with carbon dioxide.Once the cylinder is emptied, the user removes it from the handleassembly and replaces it with a new filled cylinder. Other types ofgases that may be employed, for example, are compressed air, CarbonDioxide (CO2), Nitrogen, Oxygen, Argon, Helium, Sodium Hydride, Propane,Isobutane, Butane, Chlorofluorocarbons, Dimethylether, Methylethylether, Nitrous Oxide, Hydrofluoroalkanes (HFA): either HFA 134a(1,1,1,2, -tetrafluoroethane) or HFA 227(1,1,1,2,3,3,3,-heptafluoropropane). Such arrangement provides a vastimprovement over prior pneumatically powered surgical instrumentarrangements. However, the number of times the instrument may be used isdependent upon the volume of gas that can be stored in such cylindersand the need to effectively maintain the sterility of the device.

Other embodiments of the present invention employ a cylinder 622 thatstores the material in non-gaseous, liquid state when at a storagepressure and then at least some of the liquid vaporizes when placedunder a lower pressure upon activation of the device. Examples of suchliquids that may be employed in these embodiments comprise NitrousOxide, Dimethylethyl ether, methylethyl ether, Sodium Hydride, Propane,Isobutane, Butane, Hydrofluoroalkanes (HFA): either HFA 134a (1,1,1,2,-tetrafluoroethane) or HFA 227 (1,1,1, 2,3,3,3-heptafluoropropane), andCarbon Dioxide (CO2) under higher pressures.

FIG. 57 depicts one non-limiting example of a cylinder 622 that has oneof the liquid materials 624 mentioned above therein. The cylinder 622may be fabricated from steel, aluminum or other material that iscompatible with the liquid/vapors stored therein and capable ofwithstanding the internal pressures generated therein. When employingsuch surgical instruments of the types described herein, the clinicianoften turns the handle assembly 300 in a variety of positions—includingupside-down to obtain the desired position of the end effector 12. Inthese embodiments, therefore, to prevent the liquid from undesirablymoving out of the cylinder 622 into the control system during suchmanipulation, a membrane 626 is provided within the cylinder 622. Themembrane 626 may be fabricated from material that prevents the passageof the liquid material therethrough but permits the vapor 628 formedfrom the liquid to pass through the membrane 626. Thus, the cliniciancan freely manipulate the handle assembly 300 without the danger of theliquid material 624 passing into the directional control valve 1610and/or pneumatically powered motor 1730. Although the cylinder 622 isillustrated with one piece construction, the cylinder 622 may befabricated in two or more pieces to facilitate installation of theliquid material 624 and membrane 626 therein. Appropriate seal member(s)may be employed to establish fluid-tight seals between the variousportions of the cylinder in such embodiment. In addition, a fill port(not shown) may be provided to fill the cylinder 622.

In the embodiment depicted in FIG. 57, when the clinician shifts thedirectional control valve 1610 to the forward position and activates therate valve 660, the pressure within the cylinder 622 is decreased. Suchdecrease in pressure causes the liquid material 624 to start to vaporizeand the vapor 628 passes through the membrane 626 and is used to powerthe various control systems described above. Thus, by decreasing thepressure in the cylinder 622, the liquid material 624 starts to vaporizeand the pressurized vapor 628 is used to power the device.

Other embodiments may use liquid materials that require combustion toconvert the liquid material to its gaseous state. Examples of suchliquid materials are propane, butane and other petroleum products. Aconventional pushbutton igniter or other igniter system could beemployed to ignite the liquid material. In such applications, the othercomponents of the device would be manufactured from materials and insuch a way to safely disperse any heat/fumes generated thereby. Stillother embodiments may employ phase change materials that are designedspecifically to convert from solid to fluid, solid to gas or fluid togas at a low pressure and temperature through the input of heat.Examples of these materials are paraffin and numerous mixtures of sodiumhybrids. These phase change materials may have large volumetric changeswith the input of heat to the system. Such devices would employ a meanssuch as a burner to provide the requisite heat to the material. Again,the components of these devices that may be exposed to such heat wouldbe designed and constructed from materials to safely dissipate the heatand protect the clinician during use.

The embodiment depicted in FIG. 57 may be used with variety of thedifferent types of cylinders described above and provides variousadvantages over other embodiments wherein the cylinder is permanentlymounted within the handle assembly 300. More specifically and withreference to FIG. 57, the cylinder 622 may be received within a cavity671 formed in the grip portion 342 of the handle assembly 300. To gainaccess to the cavity 671, the grip portion 342 may be manufactured intwo readily separable pieces or be provided with a removable cover panel(not shown) that snaps or is otherwise removably attached thereto. Invarious embodiments, the discharge end 630 of the cylinder 622 isthreaded into a threaded port 634 in a header block 632. The threadedport 634 communicates with a supply passage 636 that is open and closedby a needle valve 638. In particular, in various embodiments, the needlevalve 638 is threaded into the header block 632 such that the supplypassage 636 may be opened and closed by rotating the needle valve 638.However other valve or flow control arrangements may be employed.

To provide the clinician with an indication of the cylinder's pressureduring use, a conventional pressure gage 640 may be mounted in fluidcommunication with the supply passage 636. A gage window 642 may beprovided in the grip portion 342 to enable the user to view the gage 640during use. See FIG. 49.

As can be seen in FIGS. 57 and 58, the cylinder 622 may be supported ina detachable grip portion 342 that is removably attachable to a primaryattachment portion 344 that protrudes downwardly from the primary handleportion 340. The detachable grip portion 342 may be engaged with theprimary attachment portion 344 by any suitable arrangement. For example,according to various embodiments, the engagement of the detachable gripportion 342 with the primary attachment portion 344 may be realized by astraight linear slide arrangement as shown. As shown, for example, inFIGS. 57-59 and 61, the releasable grip portion 342 further comprisesfirst and second upper slide rails 367 and first and second lower sliderails 368. As can also be seen in those Figures, the first upper sliderail 367 defines a ramp 369. The upper slide rails 367 are designed tobe received within corresponding areas 384 defined in the primary handleportion 340 by panels 380 and 382.

The surgical instrument may further comprise a lockout system 1900. Thelockout system 1900, shown in greater detail, for example, in FIGS. 59and 64-69, is structured and arranged to block connection of the primaryattachment portion 344 to the detachable grip portion 342 after thedetachable grip portion 342 is disconnected from the primary attachmentportion 344 a predetermined number of times. The predetermined number oftimes may be any number of times. Such arrangement may be particularlyadvantageous in ensuring that the sterility of the device is effectivelymaintained by limiting the number of times that a device may be used.For example, according to various embodiments, the lockout system 1900may block connection of the primary attachment portion 344 to thedetachable grip portion 342 after the detachable grip portion 342 isdisconnected from the primary attachment portion 344 two times. Althoughthe lockout system 1900 is shown predominately within the primaryhousing portion 340, it is understood that according to otherembodiments the lockout system 1900 may be predominately within thedetachable grip portion 342.

As shown in FIG. 59, the lockout system 1900 comprises a counter 1902,and a blocking assembly 1904 coupled to the counter 1902. The counter1902 is structured and arranged to advance when the detachable gripportion 342 is disconnected from the primary attachment portion 344 ofthe handle assembly 300. As can be seen in FIG. 59, the counter 1902 isconnected to a shaft 1906 which is supported by a boss 1908 connected tothe right hand case member 320. The counter 1902 comprises an indexwheel 1910 coupled to the shaft 1906, and a biasing member 1912 coupledto the index wheel 1910. The biasing member 1912 may comprise, forexample, a torsion spring configured to bias the index wheel 1910 in acounterclockwise direction. See FIG. 59.

The index wheel 1910 defines protrusions 1914, 1914′, 1914″ thatcooperate with the blocking assembly 1904 to limit the advancement ofthe index wheel 1910. One of the protrusions 1914″ is structured andarranged to cooperate with the blocking assembly 1904 to blockconnection of the detachable grip portion 342 to the primary attachmentportion 344 after the grip portion 342 is disconnected from the primaryattachment portion 344 a predetermined number of times. Although theindex wheel 1910 is shown as defining protrusions 1914, 1914′, 19141″,it is understood that according to other embodiments, the index wheel1910 may define indents that cooperate with the blocking assembly 1904to limit the advancement of the index wheel 1910, and one of the indentsmay cooperate with the blocking assembly 1904 to block connection of thedetachable grip portion 342 to the primary attachment portion 344 afterthe grip portion 342 is disconnected from the primary attachment portion344 a predetermined number of times.

The shaft 1906 is structured and arranged to permit the index wheel 1910to be reset to a previous position. For example, the shaft 1906 maydefine a hexagonal shaped opening 1916, and a hexagonal shaped tool maybe inserted through an opening 1918 in the left hand case member 330(shown in FIG. 60) and into the hexagonal shaped opening 1916, thenrotated in clockwise direction to reset the index wheel 1910 to aprevious position.

As shown in FIG. 59, the blocking assembly 1904 comprises a blockingmember 1920, a blocking member guide 1922, a gate member 1924, and abiasing member 1926. The gate member 1924 is in contact with theblocking member 1920, is pivotably connected to the blocking memberguide 1922, and cooperates with the protrusions 1914, 1914′, 1914″ tolimit the advancement of the index wheel 1910. The biasing member 1926is coupled to the gate member 1924. The biasing member 1926 maycomprise, for example, a torsion spring configured to bias the gatemember 1924 in a clockwise direction. The operation of the lockoutsystem 1900 will be described in more detail hereinbelow with respect toFIGS. 64-69.

As shown, for example, in FIGS. 59-63, the handle assembly 300 furthercomprises a release system 1930 structured and arranged to initiatedisengagement of the detachable grip segment 342 from the primaryattachment portion 344. The release system 1930 is within the primaryattachment portion 344 and comprises a release button 1932, and firstand second release members 1934 connected to or integral with therelease button 1932. The first and second release members 1934 eachdefine a release ramp 1936. The release system 1930 further comprisesfirst and second release pins 1938 in contact with the respectiverelease ramps 1936, first and second lock springs 1940 in contact withthe first and second release pins 1938, and first and second ejectionsprings 1942 in contact with the first and second lower slide rails 368.See FIG. 62. As can be seen in FIG. 59, the free end 1941 of springs1940 extend through a corresponding hole 321 in the right hand casemember 320 and a corresponding hole 331 in the heft hand case member 330into corresponding holes 372 in the upper slide rails 367 to retain thedetachable grip portion 342 in engagement with the primary attachmentportion 344.

To initiate the disengagement of the detachable grip portion 342 fromthe grip attachment portion 344, the release button 1932 is advanced,causing the first and second release members 1934 and the respectiverelease ramps 1936 to also advance. As the release ramps 1936 advance,the release ramps 1936 cause the first and second release pins 1938 tochange position. The change of the respective positions of the first andsecond release pins 1938 causes the first and second lock springs 1940to move upward out of the holes 372 in the upper slide rails 367 asufficient amount to allow the first and second upper slide rails 367 toslide out of engagement therewith. As the detachable grip portion 342moves away from the primary grip attachment portion 344, each of thefirst and second ejection springs 1942 release stored energy, therebyrespectively imparting a force against each of the first and secondlower slide rails 368. The imparted force assists the disengagement ofthe detachable grip portion 342 from the primary grip attachment portion344. It is understood that, according to other embodiments, the releasesystem 1930 may comprise other components and/or configurations suitablefor initiating the release of the detachable grip portion 342 from theprimary grip attachment portion 344.

Referring to FIGS. 57 and 58, the distal end 637 of the supply passage636 has a point 639 formed thereon to enable the distal end 637 topuncture through the sterile seal membrane 646 mounted within anenclosed header chamber 644 provided in the primary attachment section344. In particular, the distal end 637 of the supply passage 636 isinserted through a port 645 in the header chamber 644. The sterilemembrane 646 may be fabricated from any suitable pierceable materialthat can be sterilized and achieve a substantially fluid-tight orairtight seal between the distal end 637 of the supply passage 636 wheninserted therethrough yet maintain the sterility of the area within theheader chamber 644 when the end 637 of the supply passage 636 is removedtherefrom.

As can also be seen in FIGS. 57 and 58, the supply line 650 isfluidically coupled to the header chamber 644 such that pressurized gasentering the header chamber 644 from the supply line 636 flows into thesupply line 650. FIG. 57 illustrates the detachable grip portion 342prior to attachment to the primary attachment portion 644. FIG. 58illustrates the grip portion 342 attached to the primary attachmentportion 344. As can be seen in FIG. 58, the distal end 637 of the supplypassage 636 has punctured through the sterile membrane 646. To assistwith the insertion of the distal end 637 of the supply passage 636through the sterile membrane, a compression spring 649 is providedbetween the wall of the detachable grip portion 342 and the header block632. Such arrangement provides some “give” to the header block 632 asthe distal end 637 of the supply passage 636 is inserted through themembrane 646.

FIGS. 64-69 illustrate the relative positions of the components of thelockout system 1900 at various times during the attachment/disconnectprocess. FIG. 64 illustrates the relative positions prior to the firstfull engagement of the grip portion 342 to the primary attachmentportion 344. The gate member 1924 is in contact with protrusion 1914thereby preventing the index wheel 1910 from advancing.

The grip portion 342 is attached to the attachment portion 344 byadvancing the slide rails 637 into the corresponding passages 384. Theblocking member 1920 protrudes into one of the passages 384 through ahole 381 in the panel 380. See FIG. 59. As the first and second upperslide rails 367 advance, the ramp 369 on one of the first upper sliderails 367 contacts the blocking member 1920 and causes it to move upwardtoward the index wheel 1910. As the blocking member 1920 advances towardthe index wheel 1910, the blocking member 1920 causes the gate member1924 to advance away from the index wheel 1910. See FIG. 65. As thefirst upper slide rail 367 and the ramp 369 continue to advance, theblocking member 1920 continues to advance toward the index wheel 1910.When the grip portion 352 is fully engaged with the primary portion 351,the blocking member 1920 is in contact with the protrusion 1914 that wasinitially in contact with the gate member 1924, thereby preventing theindex wheel 1910 from advancing as shown in FIG. 66.

After the disengagement of the grip portion 342 from the primaryattachment portion 344 is initiated, the first and second upper sliderails 367 advance in the opposite direction, the ramp 369 defined by thefirst upper slide rail 367 allows the blocking member 1920 to advanceaway from the index wheel 1910. As the blocking member 1920 advancesaway from the index wheel 1910, the blocking member 1920 allows the gatemember 1924 to advance toward the index wheel 1910 and past theprotrusion 1914 as shown in FIG. 67. As the grip portion 342 isdisconnected from the primary attachment portion 344, the blockingmember 1920 advances far enough away from the index wheel 1910 to losecontact with the protrusion 1914 and allow index wheel 1910 to rotateuntil a second protrusion 1914′ comes into contact with the gate member1924 as shown in FIG. 68.

At this point, the counter 1902 has advanced one position, and the gripportion 342 is able to be reattached to the primary attachment portion344. The attachment/disconnect cycle may be repeated. FIG. 68illustrates the second reattachment process. When the grip portion 342is fully engaged with the primary attachment portion 344, the blockingmember 1920 is in contact with the protrusion 1914″ thereby preventingthe index wheel 1910 from advancing as shown in FIG. 69. At the end ofthe second cycle, when the grip portion 342 is disconnected from theprimary attachment portion 344, the gate member 1926 is in contact witha third protrusion 1914″ as shown in FIG. 69. The third protrusion 1914″is structured and arranged to prevent the gate member 1926 from beingadvanced away from the index wheel 1910 by the blocking member 1920,thereby preventing the primary attachment portion 344 from beingreattached to the grip portion 342 (or attached to a replacement gripsection). Therefore, according to these embodiments, the surgicalinstrument is effectively a two-use instrument. However, one skilled inthe art will appreciate that the number of uses can be increased if theindex wheel 1910 defines additional protrusions or indents. Otherembodiments of the present invention lack the lockout system 1900, butis configured such that panels 382 or another portion or portions of thehandle assembly 300 break off or are otherwise disabled to prevent thereattachment of the grip portion 342 or other grip portion to the handleassembly.

FIGS. 70-83 illustrate another unique and novel pneumatically poweredsurgical cutting and fastening device 3010 of the present invention thatprovides the clinician with the ability to monitor the progress of thefiring stroke while also providing the ability to manually retract thefiring components thereof. This embodiment may be used in connectionwith the end effector 12 described above or with other end effectorarrangements.

The elongate spine assembly 3102 of this embodiment may comprise aproximal spine segment 3104 that is attached to a distal spine segment3106. In alternative embodiments, the elongate spine assembly 3102 maycomprise a single component. The elongate spine assembly 3102 issubstantially hollow and is non-movably coupled to the housing assembly300. As can be seen in FIGS. 79 and 80, the proximal end 3105 of theproximal spine segment may be attached to the housing assembly by aright attachment peg 3110 protruding from the right hand case member 320and a left attachment peg 3112 protruding from the left hand case member330. The distal end of the elongate spine member 3102 may be coupled tothe elongate channel 20 in the manner described above.

Also in this embodiment, an elongate closure tube 3190 extends from thehandle assembly 300 to the end effector 12. The distal end 3192 of theclosure tube 3190 has a horseshoe aperture 3194 therethrough and servesto interact with the open/closing tab 46 on the anvil 40 in the mannerdescribed above when the closure tube 3190 is moved axially on the spinemember 3102. See FIG. 70.

As can be seen in FIG. 71, a shuttle assembly 3400 that is coupled tothe closure trigger 302 by a linkage assembly 430 is supported withinthe primary housing portion 340. Shuttle assembly 3400 may also befabricated in two pieces 3402, 3404 (FIG. 73) that are molded orotherwise fabricated from a polymer or other suitable material and aredesigned to mate together. The pieces 3402, 3404 may be retainedtogether by snap members and/or adhesive and/or bolts, screws, clips,etc. The right hand portion 3402 of the shuttle assembly 3400 has aright retention flange segment 3405 (FIG. 72) that is adapted tocooperate with a left retention flange segment (not shown) on the lefthand portion 3404 of the shuttle assembly 3400 to form a retentionflange assembly that may extend into the retention groove (not shown) inthe proximal end 3196 of the elongate closure tube 3190 in the mannerdescribed above. The proximal end 3104 of the elongate spine member 3102extends into the opening 3403 formed in the distal end of the shuttleassembly 3400 and is non-movably attached to the right hand case member320 by the right retention peg 3110 that extends through the opening3406 and a left retention peg 3112 that extends through opening 3408 inthe right hand portion 3402 and left hand portion 3404, respectively. Inaddition, the shuttle assembly 3400 is provided with laterally extendingguide rails 3410, 3411. Rail 3410 is configured to be slidably receivedwithin a corresponding rail guide in the right hand case member 320 andrail 3411 is configured to be slidably received within a correspondingrail guide in left hand case member 330. Thus, the shuttle assembly 3400and the closure tube 3190 can move axially relative to the spineassembly 3102 that is attached to the handle assembly 300.

Axial movement of the shuttle assembly 3400 and the elongate closuretube 3190 in the distal direction (arrow “C”) is created by moving theclosure trigger 302 toward the grip portion 342 of the handle assembly300 and axial movement of the shuttle assembly 3400 in the proximaldirection (arrow “D”) is created by moving the closure trigger 302 awayfrom the grip portion 342. In various embodiments, the shuttle assembly3400 is provided with a connector tab 3412 that facilitates theattachment of the closure linkage assembly 3430 thereto. See FIGS. 71and 72. The closure linkage assembly 3430 includes a yoke portion 3432that is pivotally pinned to the connector tab 3412 by a pin 3414. Theclosure linkage assembly 3430 further has a closure arm 3434 that ispivotally pinned to a yoke assembly 304 formed on the closure trigger302 by a closure pin 3436 as illustrated in FIG. 71. The closure trigger302 is pivotally mounted within the handle assembly 300 by a pivot pin306 that extends between the right hand case member 320 and the lefthand case member 330.

When the clinician desires to close the anvil 40 and to clamp tissuewithin the end effector 12, the clinician draws the closure trigger 302toward the grip portion 342. As the clinician draws the closure trigger302 toward the grip portion 342, the closure linkage assembly 3430 movesthe shuttle assembly 3400 in the distal “C” direction until the closurelinkage assembly 3430 moves into the locked position illustrated in FIG.71. When in that position, the linkage assembly 3430 will tend to retainthe shuttle assembly 3400 in that locked position. As the shuttleassembly 3400 is moved to the locked position, the closure tube 3190 ismoved distally on the spine assembly 3102 causing the closure/openingtab 46 on the anvil 40 to be contacted by the proximal end of thehorseshoe aperture 3194 in the distal end 3192 of the closure tubesegment 3190 to thereby pivot the anvil 40 to the closed (clamped)position. To further retain the shuttle assembly 3400 in the closedposition, a locking mechanism 301 may be employed as described above.

As indicated above, these various embodiments of the present inventionemploy a unique and novel retraction rod assembly 4000 that enables theclinician to monitor the progress of the firing and retraction strokesand also provide the capability to manually retract a firing bar 4030.As can be seen in FIG. 72, the retraction rod assembly 4000 includes aretraction rod 4010 that is slidably pinned to a push bar 4020. Inparticular, the retraction rod 4010 has an elongate slot 4012therethrough that is sized to slidably receive two pins 4014 forattaching the retraction rod 4010 to the push bar 4020. A retractionhandle grip 4016 may be attached to the proximal end 4011 of theretraction rod 4010.

The push bar 4020 has a distal end 4022 that is designed to interfacewith the proximal end of an elongated firing bar 4030. As shown in FIG.72, the proximal end 4032 of the firing bar 4030 has a connector portion4034 formed thereon that sized to be received in a correspondinglyshaped connector aperture 4024 in the distal end 4022 of the push bar4020. Thus, the push bar 4020 may be used to axially push the firing bar4030 in the distal direction for a firing stroke or pull the firing bar4030 in the proximal direction for a retraction stroke. Those ofordinary skill in the art will appreciate that the firing bar 4030extends through the spine assembly 3102. In alternative embodiments, thefiring bar 4030 may have a rectangular, square, etc. cross-sectionalshape and be attached to the distal end 31 of the knife assembly 30 asdescribed above or be connected to different types of knife bars andother end effector components that require an axial motion to activatethe end effector.

FIGS. 72-77 comprise various views of shuttle assembly 3400. As can beseen in those Figures, the left hand shuttle portion 3404 includes twospaced vertical support walls 3416 and 3418 that define a push baropening 3420 therebetween. The distal end 4022 of the push bar 4020extends through the push bar opening 3420 to be coupled to the proximalend 4032 of the firing bar 4030. As can be seen in FIG. 72 the proximalend 4026 of the push bar 4020 is coupled to a “Z”-shaped connector piece4040. In particular, the proximal end 4026 of the push bar may have aconnection peg 4028 protruding therefrom that may be received in anopening 4049 in an attachment tab 4042 on the proximal end 4041 of theZ-shaped connector piece 4040. See FIG. 72. However, the proximal end4026 of the push bar 4020 may be attached to the attachment tab 4042 bya screw or other suitable fasteners. The distal end 4045 of the Z-shapedconnector piece 4040 has a distal attachment tab 4046 thereon that isadapted to be connected to a piston cylinder 5040 protruding from apneumatically powered cylinder assembly 5000.

As can be seen in FIG. 79, the cylinder assembly 5000 may comprise afirst cylinder housing 5010 that has a first closed proximal end 5012and a first open distal end 5014 that opens into a first axial passage5016 within the first cylinder housing 5010. The cylinder assembly 5000also comprises a second cylinder housing 5020 that has a second proximalend 5022 and a second open distal end 5024 that opens into a secondaxial passage 5026. The second proximal end 5022 has a first piston head5028 formed thereon that is sized relative to the first axial passage5016 to create a substantially airtight sliding seal with the first wall5011 of the first cylinder housing 5010 to define a first cylinder area5015 between the distal side of the first proximal end 5012 and theproximal side of the first piston head 5028. The first distal end 5014of the first cylinder housing 5010 further has an inwardly extendingfirst flange 5017 formed thereon for establishing a substantiallyairtight sliding seal with the outer wall surface of the second cylinderhousing 5020 to define a second cylinder area 5018 between the proximalside of the first flange 5017 and the distal side of the first pistonhead 5028.

A first passage 5027 is provided through the first piston head 5028. Ascan also be seen in FIG. 79, a piston cylinder 5040 extends through thesecond open distal end 5024 of the second cylinder housing 5020 and intosecond axial passage 5026. The piston cylinder 5040 has a proximal end5042 and a closed distal end 5044. A second piston head 5046 is formedon the proximal end 5042 of the piston cylinder 5040. The second pistonhead 5046 is sized relative to the second axial passage 5026 to create asubstantially airtight sliding seal with a second wall 5021 of thesecond cylinder housing 5020 to define a third cylinder area 5032. Thesecond distal end 5024 of the second cylinder housing 5020 further hasan inwardly extending second flange 5025 formed thereon for establishinga substantially airtight sliding seal with the piston cylinder 5040 todefine a fourth cylinder area 5034 between the proximal side of thesecond flange 5025 and the distal side of the second piston head 5046.An opening 5047 is provided through the second piston head 5046 into apassage 5048 in the piston cylinder 5040.

As can be seen in FIGS. 79 and 80, the cylinder assembly 5000 is mountedwithin the housing assembly 300. A first supply line or supply conduit5050 extends from a directional control valve 1610 in the handleassembly 300 to be coupled to the first proximal end 5012 of the firstcylinder housing 5010 to supply pressurized gas through a first supplyport 5013 or opening in the first proximal end 5012 of the firstcylinder housing 5010. In addition, a second supply line or supplyconduit 5052 extends from the directional control valve 1610 to thefirst cylinder housing 5010 adjacent the distal end 5014 thereof tosupply pressurized gas into the second cylinder area 5018 through asecond port 5029. See FIG. 78.

With reference to FIGS. 78 and 79, the extension and retraction of thefiring bar 4030 will now be explained. As can be seen in FIG. 78, thesupply lines 5050 and 5052 are coupled to a conventional directionalvalve 1610 which is part of an actuator system 1600 housed within thehandle assembly 300. The directional control valve 1610 has a forwardposition section 1620, a stop section 1630, and a reverse section 1640.The control valve sections 1620, 1630, 1640 may be manually shifted bythe push buttons 1612 and 1614 that protrude through the handle housing300. In various embodiments, a removable source 620 of pressurized gasis employed. See FIGS. 71 and 81-83. Those of ordinary skill in the artwill appreciate, however, that nonreplaceable/rechargeable sources(cylinders) of pressurized gas could also be effectively employed. Stillin other embodiments, the handle assembly 300 may be provided with aport 616 for supplying pressurized gas from an external source 618 ofpressurized gas. For example, the instrument 3010 could be coupled tothe facility's compressed air supply 618 through a flexible supply line617. See FIG. 81A.

Pressurized gas flows from the cylinder 622 (or external pressure source618) through a supply line 650 into a conventional rate valve 660. Ascan most particularly be seen in FIG. 78, the rate valve 660 is coupledto a supply linkage 662 that is attached to an activation trigger 670.In various embodiments, activation trigger 670 is supported adjacent thefiring trigger 310 that is pivotally coupled to the handle assembly 300by a pivot pin 370 that extends between the right hand case member 320and left hand case member 330. Squeezing the activation trigger 670inward towards the firing trigger 310 causes the rate valve 660 topermit more pressurized gas to pass therethrough into a supply line 680into the directional valve 1610. Depending upon the position of thedirectional valve 1610, the pressurized gas will either flow into supplyline 5050 or 5052. For example, when the directional valve 1610 isactuated by the clinician to extend the firing bar 30, the control valve1610 is shifted to the forward position such that forward passage 1622permits the pressurized gas to flow from the supply line 680 into thesupply line 5050. Gas flowing through supply line 5050 enters into thefirst cylinder area 5015 (FIG. 79) through the first supply port 5013 inthe closed end 5012 and through the opening 5027 in the first pistonhead 5028 and into the third cylinder area 5032. The pressurized gasentering the third cylinder area 5032 also passes through the opening5047 in the second piston head 5046 into the hollow piston cylinder 5040and forces the piston cylinder 5040 distally. Gas located in the fourthcylinder area 5034 vents therefrom through exhaust opening 5023 in thesecond cylinder housing 5020. Similarly, the gas located in the secondcylinder area 5018 is permitted to vent therefrom through second opening5029 into the second supply line 5052. The second supply line 5052carries the vented gas to passage 1624 in directional valve 1610 (FIG.78) wherein it is ultimately vented from vent passage 1632. Continuedapplication of pressurized gas to the first cylinder area 5015, thethird cylinder area 5032, and passage 5048 in the piston cylinder 5040causes the piston cylinder 5040 to extend distally as shown in FIGS. 73and 79. As the piston cylinder 5040 extends distally, the Z-shapedconnector also 4040 extends distally by virtue of its attachment to thedistal end 5044 of the piston cylinder 5040. The Z-shaped connector 4040forces the push bar 4020 distally which also forces the firing bar 4030distally. As the firing bar 4030 moves distally, the distal end portion31 of the knife assembly 30 attached thereto is advanced through thecartridge 50 to sever the tissue clamped in the end effector 12 and firethe staples. Once the knife assembly 30 has been advanced to itsdistal-most position in the end effector 12, the clinician discontinuesthe application of pressurized gas by releasing the activation trigger670.

This embodiment may also be provided with a means for indicating whenthe knife assembly 30 has reached its distal most position in thecartridge 50. In particular, a distal pilot line 1772 may be providedfrom the supply line 650 to the distal limit switch 1770. A distal limitswitch line 1774 is provided between the distal limit switch 1770 andthe directional control valve 1610. Thus, when the knife assembly 30 hascompleted the firing stroke the distal limit switch 1770 is so orientedrelative to a portion of the cylinder assembly 5000 such that it isactivated by a portion thereof. The distal limit switch 1770 permits theair to flow under pressure from the supply line 650 to the distal limitswitch line 1774 and into the directional control valve 1610 which, invarious embodiments, causes the directional control valve 1610 toautomatically shift to the reverse position which, as will be discussedbelow causes the firing bar 4030 to be retracted. In variousembodiments, a first air powered whistle 1790 or other suitable soundgenerating device may communicate with the distal limit switch line 1774(or distal limit switch 1770) such that when the distal limit switch1770 is actuated at the end of the firing stroke, air passing throughthe distal limit switch line 1774 activates the first whistle 1790 toprovide the clinician with an audible signal indicating that the knifeassembly 30 has reached the end of the firing stroke. In alternativeembodiments, pressure switches gages, etc. may be used in place ofwhistle 1790 to provide the clinician with an indication of when theknife assembly 30 has reached the end of the firing stroke.

To pneumatically retract the firing bar 4030, the clinician may pushbutton 1614 to shift the control valve 1610 to the reverse position andbegins to squeeze the activation trigger 670 which causes thepressurized gas to flow into the second supply line 5052. Gas flowingthrough the second supply line 5052 enters the second cylinder area 5018which causes the second cylinder housing 5020 to retract proximally intothe first cylinder housing 5010. Gas in the first cylinder area 5015 ispermitted to vent through the first supply opening 5013 into the firstsupply line 5050. Gas passing through the first supply line 5050 entersthe directional valve 1610 wherein it is vented from vent 1632. Once thepressurized gas entering the second cylinder area 5018 has caused thesecond cylinder housing 5020 to retract into the first cylinder housing5010, gas passing through the second opening 5029 is now able to passthrough the exhaust opening 5023 in the second cylinder housing 5020 andinto the fourth cylinder area 5034. As pressurized gas enters the fourthcylinder area 5034, the second piston head 5046 draws the pistoncylinder 5040 proximally into the second cylinder housing 5020. Gas inthe third cylinder area 5032 passes through the first opening 5027 intothe first cylinder area 5015 from which it is vented in the mannerdescribed above. As the piston cylinder 5040 is retracted, the Z-shapedconnector 4040 moves proximally and pulls with it the push bar 4020 andthe firing bar 4030 which is attached thereto.

In various embodiments, a proximal pilot line 1662 also extends betweena proximal limit switch 1660 and the supply line 650. See FIG. 78 Theproximal limit switch 1660 is so oriented relative to the cylinderassembly 5000 or the connector 4040 such that when the firing bar 4030has been completely retracted, the proximal limit switch 1760 isactuated and then permits air to flow into a proximal limit switch line1764 and into the directional control valve 1610 to cause thedirectional control valve 1610 to automatically shift to the stoppedposition. In alternative embodiments, a second air powered whistle 1792or other suitable sound generating device may communicate with theproximal limit switch 1760 such that when the proximal limit switch 1760is actuated at the end of the retraction stroke, gas passing through theproximal limit switch line 1764 activates the second whistle 1792 toprovide the clinician with another audible signal indicating that thefiring bar 4030 and knife portion 30 have reached the end of theretraction stroke. In other embodiments, for example, battery poweredlight emitting diodes or other signal devices may communicate with thedistal and proximal limit switches 1770, 1760 to provide the user withanother indication when the wedge sled/knife has reaches the end of thefiring stroke and/or the retraction stroke. Those of ordinary skill inthe art will readily appreciate that, if during the firing stroke, theclinician wishes to stop the firing stroke and retract the firing barand knife, all he or she has to do is manually switch the control valve1610 to the reverse position.

In the above-described examples, the clinician did not employ the uniqueand novel retraction rod assembly 4000 of this embodiment of the presentinvention. The reaction rod assembly has multiple advantages. First, ifduring the course of the firing or retraction strokes, pneumatic poweris inadvertently lost due, perhaps to an empty supply cylinder 620 orotherwise due to an inadvertent interruption in the supply ofpressurized gas, the clinician can manually retract the firing bar (andknife assembly 30) simply by manually shifting the control valve 1610 tothe reverse position and grasping the handle grip 4016 attached to theproximal end of the retraction rod and pulling the rod in the proximaldirection until the firing bar has been completed retracted. See FIG.83. By shifting the control valve 1610 to the reversed position enablesthe gas in the cylinder assembly to be vented as the knife bar isretracted.

Another advantage provided by this embodiment of the present inventionis the ability to visually monitor the firing progress of the firing barand knife portion as they move distally during the firing stroke. Thisadvantage may be attained simply by pulling the retraction rod to itsproximal most position shown in FIG. 83 prior to commencing the firingstroke. When in that position, as the cylinder assembly 5000 advancesthe connector 4040, push bar 4020 and firing bar 4030 distally, the pushbar 4020 draws the retraction bar 4010 distally with it by virtue of thepinned connection therewith. In various embodiments, the length of theretraction rod 4010 is provided such that when the firing bar 4030 isfully extended, no portion of the retraction rod 4010 protrudes from thehandle assembly 300. Thus, the clinician can determine the progress ofthe firing bar 4030 and knife assembly 30 by observing the portion ofthe retraction rod 4010 protruding from the handle assembly 300.

In alternative embodiments shown in FIGS. 72A and 83A, the retractionrod 4010 may be provided with at least one and preferably at least twonotches 4015 for receiving the pins 4014 therein. Those of ordinaryskill in the art will appreciate that such arrangement will provide theclinician with the ability to visually monitor the progress of thefiring bar 4030 and knife assembly 30 during the retraction stroke. Inparticular, as the firing bar 4030 is retracted, the push bar 4020causes the retraction rod 4010 to advance proximally out of the housingassembly 300 by virtue of the pins 4014 engagement in the notches 4015.Thus, the clinician can judge the distance the firing bar 4030 hasprogressed during the retraction stroke by observing the distance thatthe retraction rod 4010 protrudes out of the handle assembly 300.However, when the instrument is not in use, the retraction rod 4010 canbe pushed into the handle assembly to the position shown in FIG. 81.

While several embodiments of the invention have been described, itshould be apparent, however, that various modifications, alterations andadaptations to those embodiments may occur to persons skilled in the artwith the attainment of some or all of the advantages of the invention.For example, according to various embodiments, a single component may bereplaced by multiple components, and multiple components may be replacedby a single component, to perform a given function or functions. Thisapplication is therefore intended to cover all such modifications,alterations and adaptations without departing from the scope and spiritof the disclosed invention as defined by the appended claims.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include an combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of particular pieces or parts of thedevice can be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Those ofordinary skill in the art will appreciate that the reconditioning of adevice can utilize a variety of different techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

Preferably, the invention described herein will be processed beforesurgery. First a new or used instrument is obtained and, if necessary,cleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK® bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or higher energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

The invention which is intended to be protected is not to be construedas limited to the particular embodiments disclosed. The embodiments aretherefore to be regarded as illustrative rather than restrictive.Variations and changes may be made by others without departing from thespirit of the present invention. Accordingly, it is expressly intendedthat all such equivalents, variations and changes which fall within thespirit and scope of the present invention as defined in the claims beembraced thereby.

1. A surgical instrument for use in connection with a pneumaticallypowered tool having a firing mechanism operably supported therein thatis movable between an unactuated position and an actuated position, saidsurgical instrument comprising: a handle assembly operably couplable tothe pneumatically powered tool; a pneumatically powered drive system atleast partially supported by said handle assembly and operablycommunicating with the pneumatically powered tool, said pneumaticallypowered drive system being configured to selectively apply at least afiring force to the firing mechanism of the pneumatically powered toolof sufficient magnitude to cause the firing mechanism to move from theunactuated position to the actuated position in response to a flow ofgas from a source of gas fluidically coupled to said pneumaticallypowered drive system; and at least one feedback device operablysupported by said handle assembly and communicating with saidpneumatically powered drive system for providing feedback concerning:(a) the magnitude of said firing force as said pneumatically powereddrive system moves the firing mechanism from the unactuated to actuatedposition; and (b) a relative position of the firing mechanism as thefiring mechanism is pneumatically moved between the unactuated andactuated positions.
 2. The surgical instrument of claim 1 wherein saidmagnitude of said firing force is substantially proportional to apressure of said flow of gas from said source of gas to saidpneumatically powered drive system as said pneumatically powered drivesystem moves the firing mechanism from the unactuated to actuatedposition.
 3. The surgical instrument of claim 1 wherein said at leastone feedback device provides a visual indication of the magnitude ofsaid firing force as the pneumatically powered drive system moves thefiring mechanism from the unactuated position to the actuated position.4. The surgical instrument of claim 3 wherein said at least one feedbackdevice comprises a pressure gage in fluid communication with a supplyline fluidically coupling said source of gas to said pneumaticallypowered drive system.
 5. The surgical instrument of claim 3 wherein saidfeedback device at least provides an audible sound that has a pitch thatvaries in proportion to the magnitude of the firing force beinggenerated as the firing mechanism is moved from the unactuated toactuated position.
 6. The surgical instrument of claim 5 wherein said atleast one feedback device comprises at least one orifice in a supplyline fluidically coupling said source of gas to said pneumaticallypowered drive system.
 7. The surgical instrument of claim 1 wherein saidfeedback device provides a visual indication of a relative position ofthe firing mechanism between the unactuated and actuated positions asthe firing mechanism is moved therebetween by said pneumatically powereddrive system.
 8. The surgical instrument of claim 1 wherein said atleast one feedback device comprises: a first visual feedback device forindicating the magnitude of said firing force as said pneumaticallypowered drive system moves the firing mechanism from the unactuated toactuated position; and a second visual feedback device for indicating arelative position of the firing mechanism as the firing mechanism ismoved between the unactuated and actuated positions.
 9. The surgicalinstrument of claim 1 wherein said at least one feedback devicecomprises a firing stroke indicator communicating with saidpneumatically powered drive system to provide an indication when thefiring mechanism has reached the actuated position.
 10. The surgicalinstrument of claim 9 wherein said pneumatically powered drive system isfurther configured to selectively apply a retraction force to the firingmechanism of the pneumatically powered tool to cause the firingmechanism to move from the actuated position to the unactuated positionin response to another flow of said gas from said source of gas andwherein when the firing mechanism reaches said actuated position, saidfiring stroke indicator communicates with a flow control device in fluidcommunication with said source of gas and said pneumatically powereddrive system to cause said flow of gas to said pneumatically powereddrive system to be discontinued and permit said another flow of gas toflow to said pneumatically powered drive system to cause saidpneumatically powered drive system to apply said retraction force to thefiring mechanism.
 11. A surgical instrument for use in connection with apneumatically powered tool having a firing mechanism operably supportedtherein that is movable between an unactuated position and an actuatedposition, said surgical instrument comprising: drive means forselectively applying at least a firing force to the firing mechanism ofthe pneumatically powered tool of sufficient magnitude to cause thefiring mechanism to move from the unactuated position to the actuatedposition in response to a flow of gas from a source of gas fluidicallycoupled to said drive means; and means for providing feedbackcommunicating with said drive means for providing feedback concerning:(a) the magnitude of said firing force as said drive means moves thefiring mechanism from the unactuated to actuated position; and (b) arelative position of the firing mechanism as the firing mechanism ispneumatically moved between the unactuated and actuated positions.
 12. Asurgical instrument comprising: a handle assembly; a closure driveoperably supported by said handle assembly and configured to generate aclosing motion and an opening motion; an elongate shaft assemblyoperably coupled to said handle assembly and communicating with saidclosure drive to transfer said opening and closing motions; apneumatically powered drive system supported by at least one of saidhandle assembly and said elongate shaft assembly and being configured toselectively generate at least one of a firing force and a retractionforce; an end effector coupled to said elongate shaft assembly, said endeffector comprising: an elongate channel sized to receive a staplecartridge therein; an anvil pivotally coupled to said elongate channeland being pivotally responsive to said open and closing motions fromsaid elongate shaft assembly; and a firing mechanism operably supportedwithin one of said elongate channel and the staple cartridge and beingmovable from an unactuated position to an actuated position in responseto an application of said firing force from said pneumatically powereddrive system and being movable from said actuated position to saidunactuated position in response to another application of saidretraction force from said pneumatically powered drive system andwherein said surgical instrument further comprises: at least onefeedback device communicating with said drive system for providingfeedback concerning: (a) a magnitude of said firing force as said drivesystem moves the firing mechanism from the unactuated to actuatedposition; and (b) a relative position of the firing mechanism as thefiring mechanism is pneumatically moved between the unactuated andactuated positions.
 13. The surgical instrument of claim 12 wherein saidpneumatically powered drive system comprises a drive member configuredto generate a firing force in response to a flow of gas from a source ofpressurized gas fluidically coupled thereto and a retraction force andwherein said drive member is selected from the group of drive membersconsisting essentially of: a pneumatically powered cylinder, apneumatically powered bellows assembly and a pneumatically poweredmotor.
 14. The surgical instrument of claim 12 wherein saidpneumatically powered drive system comprises: a source of pressurizedgas; a pneumatically powered drive member fluidically coupled to saidsource of pressurized gas; a flow control switch fluidically coupled tosaid pneumatically powered drive member and said source of pressurizedgas for controlling flow of pressurized gas to said pneumaticallypowered drive member from said source of pressurized gas.
 15. Thesurgical instrument of claim 14 wherein said at least one feedbackdevice comprises a firing stroke indicator cooperating with saidpneumatically powered drive member to provide an indication when thefiring mechanism has reached the actuated position, said firing strokeindicator communicating with said flow control switch such that when thefiring mechanism reaches the actuated position, said firing strokeindicator causes said flow to switch to discontinue said flow of gas tosaid pneumatically powered drive member and permit said another flow ofsaid gas to flow to said pneumatically powered drive member to causesaid pneumatically powered drive member to apply said retraction forceto the firing mechanism.
 16. The surgical instrument of claim 15 whereinsaid at least one feedback device further comprises: a first visualfeedback device for indicating the magnitude of said firing force assaid pneumatically powered drive member moves the firing mechanism fromthe unactuated to actuated position; and a second visual feedback devicefor indicating a relative position of the firing mechanism as the firingmechanism is moved between the unactuated and actuated positions. 17.The surgical instrument of claim 15 wherein said at least one feedbackdevice further comprises a pressure gage in fluid communication with asupply line fluidically coupling said source of gas to saidpneumatically powered drive member.
 18. The surgical instrument of claim15 wherein said at least one feedback device further comprises anotherfeedback device that provides an audible sound that has a pitch thatvaries in proportion to the magnitude of the firing force beinggenerated as the firing mechanism is moved from the unactuated toactuated position.
 19. The surgical instrument of claim 15 wherein saidat least one feedback device further comprises at least one orifice in asupply line fluidically coupling said source of gas to saidpneumatically powered drive member.